Community Occupational Therapy in Dementia intervention for people with mild to moderate dementia and their family carers in the UK: the VALID research programme including RCT

Article history

The research reported in this issue of the journal was funded by PGfAR as project number RP-PG-0610-10108. The contractual start date was in January 2012. The final report began editorial review in February 2019 and was accepted for publication in April 2022. As the funder, the PGfAR programme agreed the research questions and study designs in advance with the investigators. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PGfAR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.

Copyright statement

Copyright © 2023 Wenborn et al. This work was produced by Wenborn et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.

2023 Wenborn et al.

Defining dementia

‘Dementia is a term used to describe a range of cognitive and behavioural symptoms that can include memory loss, problems with reasoning and communication and change in personality, and a reduction in a person’s ability to carry out daily activities, such as shopping, washing, dressing and cooking’ (© NICE 2018. Dementia: Assessment, Management and Support for People Living with Dementia and Their Carers. Available from www.nice.org.uk/guidance/ng97 All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication). 1 There are a range of conditions that cause dementia, the most common in the UK being Alzheimer’s disease, as well as vascular dementia, mixed dementia, dementia with Lewy bodies and frontotemporal dementia amongst others. A person with dementia finds it increasingly difficult to remember, know where they are, know who other people are, keep track of time, organise themselves and their activities, understand what is being said, communicate with other people, make decisions, or learn new things. As a result, the person experiences increasing difficulty in carrying out activities of daily living (ADL) and other valued and meaningful activities; they progressively need more and more assistance from family and friends, as well as from professional carers. The way in which carers support a person with dementia to cope with their impairments can either optimise or decrease the individual’s performance and as a result can dictate the degree of disability and lack of agency or sense of control that is experienced. 2,3

The number of people living with dementia

It is estimated that 47 million people worldwide were living with dementia in 2015 and, although the number is still rising globally owing to an ageing population, the incidence is decreasing in some countries because of the take up of public health information to adopt healthier lifestyles. 4 The 2015 UK figure was estimated to be 850,000 people living with dementia, with almost two-thirds living in the community. 5

The impact of caring for a person living with dementia

The current financial cost to the NHS, local authorities and families in England is £26.3B per year, of which £11.6B is attributable to the support provided by unpaid carers (i.e. primarily family members). 5 Indeed, unpaid care accounts for three-quarters of the total cost for people living with dementia within the community. 5 The impact of caring for someone living with dementia is not only financial, but can also be both physically and psychologically demanding. As the person with dementia loses the ability to carry out everyday tasks and their former activities and roles, family carers often experience a feeling of increased burden and stress. About 40% of family carers of people with dementia have clinically significant depression or anxiety; carers can also have poorer physical health, more absences from work and lower quality of life than non-carers. 4 Carer stress predicts care home admission and elder abuse. 4

Living Well with Dementia: a policy priority

Several UK Government policies aim to improve health and social care service provision for people with dementia and their carers. A watershed point in England was the publication of Living Well with Dementia: A National Dementia Strategy,6 the first significant policy document to address these issues. This strategy had three main aims: (1) raise awareness and understanding, (2) provide earlier diagnosis and support, and (3) maximise living well with dementia. The strategy was underpinned by 17 objectives to be achieved over 5 years. The subsequent Prime Minister’s Challenges7,8 urged action to do more to achieve the strategy first by 2015, and then by 2020, and thus raised the profile of dementia as being a clinical and research priority. 7,8 The UK Government subsequently pledged to provide community-based programmes that aimed to improve quality of life for people with dementia and their carers. 9

Training and supporting carers and tailoring psychosocial interventions to meet the specific needs of individuals are key components to achieving the dementia strategy objectives. Personalised interventions can improve family carers’ well-being, delay admission to care homes and reduce the risk of institutionalisation by up to one-third. 10,11 More recently, and following on from the drive for earlier diagnosis,12 the importance of providing psychosocial interventions for people with dementia has been emphasised both internationally13 and nationally. 14

Psychosocial interventions

Psychosocial interventions, which include physical, cognitive or social activities, can have positive and cost-effective outcomes on cognition, quality of life and institutionalisation. 15,16 Since this research programme commenced (2012), funding for psychosocial dementia research has increased and a range of interventions have been, and are being, developed and evaluated through randomised controlled trials (RCTs) and other methodologies. UK-funded studies cover a range of interventions, for example Dementia And Physical Activity,17 brief interventions to promote independence18 and tailored activities. Furthermore, a multicentre RCT of goal-oriented cognitive rehabilitation (the GREAT trial) demonstrated good achievement of goals but no benefit to validated outcomes,19 and an implementation study is about to commence.

Defining occupational therapy

Humans have an innate need to engage in personally meaningful activities to maintain physical and mental health and well-being. People who have dementia increasingly need support to engage in such activities. 2 Occupational therapy is a complex, dynamic process that comprises multiple practices, the implementation of which is individualised, with the relationship between the person(s) and the therapist being fundamental because the process necessitates the active involvement of the person(s) and therapist working in partnership. 20 Occupational therapists utilise core skills to engage people in personally meaningful occupation. They collaborate with the client (often including the client’s family and/or carer as well) in assessment, enablement, problem-solving, environmental assessment and adaptation, and use activity as a therapeutic tool. 21 Hence, engaging in meaningful activity is both the means and the outcome of the occupational therapy process and intervention.

Community Occupational Therapy in Dementia

In the Netherlands, Graff et al. 22 developed the Community Occupational Therapy in Dementia (COTiD) programme. It comprises 10 1-hour sessions of home-based occupational therapy provided over 5 weeks by an occupational therapist who works in partnership with the person who has dementia and their family caregiver on individualised goals to improve skills in meaningful daily activities through the use of effective strategies, adaptation of the (physical and social) environment, and developing the caregivers’ abilities and sense of competence. A single-site RCT of 135 pairs of people with mild to moderate dementia and their family caregivers (n = 270) compared COTiD with treatment as usual (TAU), which did not include any occupational therapy provision. The study demonstrated improved ADL skills, quality of life and mood in people with dementia, and improved quality of life, mood and sense of competence in family caregivers. 23,24 COTiD was also found to be cost-effective. 25 A subsequent study in Germany found no difference between providing COTiD and providing a single consultation visit by an occupational therapist. 26 Although the comparator group in this latter trial was different, the integral process evaluation highlighted the need not only to translate but also to adapt complex interventions to the local context for evaluation and cross-national comparison to be effective. 27 COTiD is now being translated, adapted and evaluated in other European countries. A pilot study is under way in France, and a prospective cohort study in Italy has demonstrated positive effect on caregiver burden, as well as improved activities performance and satisfaction for people with dementia. 28

UK occupational therapy practice

Currently, people with dementia living in England may or may not see an occupational therapist at the point of diagnosis and, if they do, only briefly, primarily for assessment of risk and support needs. Traditionally, occupational therapy has been provided later on in the dementia pathway; however, this is changing as a result of implementation of the previously described policy that promotes earlier diagnosis and easy access to post-diagnostic support services. At whatever point the occupational therapy is provided, the focus is invariably on the person with dementia, with their family carers’ needs considered primarily in terms of their ability to support the person with dementia within their role as a carer. Occupational therapy is not often geared towards meeting the carer’s personal or occupational needs.

The Graff study23–25 demonstrated the potential value of the occupational therapy intervention being provided at an earlier point, with a focus not only on the person with dementia but also on enabling and skilling up their family carer, who will inevitably be required to provide increasing support for the person with dementia if they are to remain engaged in meaningful activities, while also meeting their own needs, including occupational balance. It therefore appeared that COTiD had great potential for adoption in the UK. However, the culture, health and social care service provision and context differs between the Netherlands and England. At the time of the Graff study, people in the Netherlands were diagnosed with dementia by either a neurologist or a geriatrician within an outpatient clinic. There was no community occupational therapy nor older people’s mental health service provision for people with dementia within the Dutch insurance-based model of health care. Within the UK, health care has long been provided free at the point of delivery through the NHS. At the point of designing this research programme, specialist older people’s mental health services were well established, with multiprofessional teams, including occupational therapists, providing assessment and intervention services within hospital and community settings, including people’s own homes. Memory Assessment Services were just being established to provide early diagnosis and access to a range of support for people with dementia and their family carers. The UK National Institute for Health and Care Excellence (NICE) recommends that occupational therapy should be considered to support functional ability in people living with mild to moderate dementia. 1 The current Memory Services National Accreditation Programme standard 6, ‘psychosocial interventions’, requires services to provide timely access to psychosocial interventions for occupational and functional aspects of dementia, including access to occupational therapy, and access to advice and support on assistive and telecare solutions designed to assist people with ADL: a core domain of occupational therapy practice. 29

Therefore, this applied research programme, Valuing Active Life in Dementia (VALID), was funded to translate, adapt, develop, evaluate and implement a community occupational therapy intervention for people with mild to moderate dementia and their family carers in England.

Programme aim

The aim of the VALID programme was to translate, adapt, develop, evaluate and implement a community occupational therapy intervention that will promote independence, meaningful activity and quality of life for people with mild to moderate dementia and their family carers within England.

Programme structure

The VALID programme followed the Medical Research Council framework for developing and evaluating complex interventions30 and comprised three phases and five associated work packages (WPs): development (WP1 and WP2), piloting and evaluation (WP3 and WP4), and implementation (WP5). Figure 1 illustrates the sequence of WPs and activities across the programme. Table 1 summarises the WPs and their respective aims and activities.

FIGURE 1.

The VALID research pathway diagram.

Changes to the original research plan

The research aim and six out of the seven objectives remained the same; however, the timing and design of the programme were revised, as described in the following section.

Programme management and governance

Trial management and governance (work packages 3 and 4 only)

The RCT was run by the NIHR UK Clinical Research Collaboration (UKCRC)-registered Priment Clinical Trials Unit at University College London (UCL), which provides specialist expertise in the design, conduct and analyses of trials in primary care and mental health. The trial was set up and conducted in accordance with Priment quality management systems and standard operating procedures (SOPs) for non-Clinical Trials Of An Investigational Medicinal Product.

Aims

The aims of the development phase were to translate and adapt the COTiD guidelines and training package to maximise its suitability and feasibility for use within the UK and to produce the COTiD-UK intervention in readiness for evaluation in a RCT.

There were two WPs:

1. WP1 – translation and adaptation of the COTiD intervention and training package

2. WP2 – online survey to scope current community occupational therapy service provision and practice for people with dementia and their family carers in the UK.

Ethics approval

Full ethics approval for WP1 and WP2 was gained from NRES Committee Yorkshire & the Humber – Leeds West on 28.11.12, Ref No 12/YH/0492. Five amendments (four substantial and one non-substantial) were approved to cover protocol and documentation updates, and new documents as needed. Local research and development governance approvals were obtained at each research site as appropriate. Informed consent was received from all participants.

The COTiD guideline and training package

As described earlier, the COTiD guideline and training package was developed in the Netherlands and published in Dutch,23 and subsequently in French33 and Italian. 34

Development of COTiD-UK

Work package 1: translation and adaptation of the COTiD intervention and training package

Work package 2: online survey to scope current community occupational therapy service provision and practice for people with dementia and their family carers in the UK

The aims of the online survey were to identify current UK occupational therapy service provision and practice for people living with dementia and their family carers, and to explore the potential facilitators of and barriers to implementing COTiD in the UK.

Finalising the COTiD-UK intervention and training package in readiness for the evaluation phase

Aim

The aim of this phase was to determine the clinical effectiveness and cost-effectiveness of the COTiD-UK intervention compared with TAU.

There were two WPs:

1. WP3 – internal pilot trial.

2. WP4 – full RCT.

Hypotheses

It was hypothesised that, compared with TAU, COTiD-UK would:

1. significantly improve ADL in people with dementia

2. significantly improve quality of life for the people with dementia and their family carers

3. demonstrate cost-effectiveness.

Ethics approval

NHS ethics approval for WP3 and WP4 was gained from the NRES Committee London – Camberwell St Giles on 14 July 2014 (reference number 14/LO/0736). Eighteen amendments (13 non-substantial and five substantial) were approved to cover protocol and trial documentation updates; the addition of new trial sites and participant identification centres, registration with Join Dementia Research and new trial documentation as required; and postgraduate student studies linked to the VALID programme (as outlined in Development of research capacity). The appropriate local research and development governance approvals were obtained at each research site.

Written informed consent was obtained from all participants.

Work package 3: internal pilot trial

The aim of WP3 was to conduct an internal pilot trial of COTiD-UK compared with TAU to:

1. field test the outcome measures to be used to measure the effectiveness of COTiD-UK

2. finalise the intervention modes of delivery and associated training and supervision of those delivering COTiD-UK

3. field test trial procedures.

Work package 4: full randomised controlled trial

The aim of WP4 was to conduct a RCT to:

1. determine the clinical effectiveness of COTiD-UK compared with TAU

2. determine the cost-effectiveness of COTiD-UK compared with TAU.

Work package 3 was designed as an internal pilot, with the intention of moving forward into WP4, the full RCT, if predefined success criteria based on the Acceptance Checklist for Clinical Effectiveness Pilot Trials (ACCEPT) model were met. 44 This checklist provides a systematic basis for assessing whether or not a pilot trial has adequately tested a study design, methods and procedures, and, therefore, whether or not the pilot data can be integrated into the full trial data set without compromising trial integrity. There are three potential outcomes:

1. Unequivocal acceptance of pilot data – the design and methods are confirmed as being feasible and appropriate except for minor details; therefore, pilot data can be carried forward to the main trial data set.

2. Conditional acceptance – the design and methods are found to be feasible and appropriate in principle but need refinement; therefore, a decision including the pilot data must be delayed until the variation in procedures for the full pragmatic trial is known.

3. Non-acceptance of pilot data – the need for substantial change is identified; therefore, the pilot data cannot be carried forward to the main trial data set.

Method

Results

Taking part in the COTiD-UK intervention

Why people declined to take part in the research trial

The methodology and findings of the qualitative interviews with family carers who declined to take part in the RCT are reported in detail elsewhere63 and, therefore, are summarised here.

Work package 1: the cost of COTiD training and economic evaluation feasibility analysis

A preliminary analysis to assess the cost of providing the COTiD training and intervention in WP1 was carried out. These costs were updated after the trial and the results are reported in the following section. The main cost components associated with the training were venue hire, trainer costs, occupational therapist attendance, consumables and audio-feedback supervision. The main cost components associated with providing the COTiD intervention in practice were session time (including preparation and recording time) and occupational therapist travel time and cost.

Work packages 3 and 4: cost–utility analysis of COTiD-UK compared with treatment as usual

Implementation of COTiD-UK in practice (work package 5)

The aim of this WP was to determine the feasibility and effectiveness of implementing COTiD-UK into day-to-day practice. At the grant application stage, it had been planned to complete this WP after the RCT; however, the range and depth of data collected during the development, piloting and evaluation phases had made some of the planned activities redundant by then, or impracticable to complete, as explained in the following sections. This amendment to the programme structure also reflects advances in the field of implementation science since the grant application, with the current recommendation being to integrate such activities throughout this type of programme. 31 Vernooij-Dassen and Moniz-Cook31 highlight the importance of avoiding the risk of ‘implementation error’ or low intervention fidelity that can occur when conducting pragmatic trials in real-life practice settings, as low fidelity can result in the degree of effectiveness of an intervention being poorly estimated. It is also important to examine the context within which the intervention was delivered so as to better understand what factors enabled or hindered its delivery within a real-life practice setting.

Assessing intervention fidelity

Interpreting data about intervention effectiveness requires an assessment of which intervention components were delivered and whether or not they were delivered as planned (i.e. the fidelity of delivery). 87,88 Two fidelity studies were conducted alongside the RCT and are reported in detail elsewhere89 and, therefore, are summarised here.

Why was the intervention delivered or not delivered as planned?

It is important not only to measure the degree to which the intervention was delivered as planned, but also to understand the factors that enabled or hindered its delivery within a real-life practice setting. This requires understanding and reporting the context within which the intervention was delivered. 90 The context can be multilayered, that is at the individual, team, organisational and community levels. 31 This is particularly important to consider within a multisite trial, in which the context will inevitably differ between and within sites. A degree of variability is, therefore, to be expected owing to the range of occupational therapists, who have mixed levels of prior knowledge, expertise and motivation, as well as their degree of COTiD-UK specific experience, and who are delivering the intervention across a number of sites, geographical areas, clinical and service settings, to participants with differing characteristics and levels of engagement. The more complex the intervention, the more context dependent it becomes, particularly for interventions that depend on the active participation of those both delivering and receiving the intervention, which in the case of COTiD-UK is made more complex by the dyadic nature of the intervention.

Conclusion

This exploratory study to understand why the intervention was, or was not, delivered as planned highlighted the multi-layered and complex context that affected COTiD-UK delivery across the sites. The TDF domains identified as being the most relevant to COTiD-UK implementation in practice were knowledge and skills (capability), environmental context and resources (opportunity), and beliefs about capabilities (motivation).

Aim

The aim of involving people living with dementia, family carers of people with dementia and the general public in the VALID research programme was to help ensure that the research design and activities were relevant to people with dementia and their family carers, and feasible in practice.

Methods

Results

Discussion and conclusions

Here, we will discuss how well the PPI strategic principles were achieved across the programme. First, in relation to the level and nature of service user and carer involvement, there was certainly systematic and interactive consultation and collaboration, all of which were planned, identified, recorded and reviewed. Consultation included developing the grant application and research design and reviewing participant recruitment materials. Collaboration included qualitative data analysis and producing key outputs, such as the VALID newsletter and website. Members expressed some frustration about the constraints imposed on the format and content needed in producing research documents if they were to meet the requirements for gaining ethics approval, which was not felt to be user-friendly for people with cognitive impairment. Opportunities for service users and/or carers to lead the research were not identified. However, two of the three PPI reference group members have gone on to work as peer researchers on a subsequent study led by the same chief investigator, encouraged by the experience and interest gained through their involvement with VALID.

Second, PPI reference group members were involved in research processes, such as joining research staff recruitment panels, contributing to the training provided to the occupational therapists delivering COTiD-UK during the RCT, qualitative data analysis and interpretation, and dissemination activities, such as producing the VALID newsletter and updating the website.

Third, the need to support lay members to contribute to meetings was recognised, and a number of strategies were co-produced through the PPI reference group to enable their participation, for example the PPI lead co-applicant circulated the ‘VALID PPI Strategic Principles’ document to the PMG, PSC and DMEC chairpersons to raise their awareness of the importance of enabling lay members to participate effectively in meetings, and offered some practical suggestions as to how this might be achieved. The PSC chairperson met with lay colleagues (either face to face or over the telephone) in advance of the meeting to provide an explanation of the reports provided and the topics likely to be discussed; they also offered to debrief PPI members following the meetings if they wished. An administrative standard practice was to provide all meeting documents 2 weeks beforehand, posting them in hard copy if preferred, as well as sending them electronically, together with an explanation as to the purpose of each. A glossary of general research and specific VALID terms was produced and constantly updated, and included in all meeting papers along with an organisational chart initiated and developed by a member of the PPI reference group, which was also made available on the VALID website.

Finally, the PPI reference group had planned to review the PPI experience across the trial research sites. A procedure for contacting sites to identify the relevant PPI contact locally was agreed. However, despite numerous follow-up attempts made by the group, the PPI lead and members of the wider support team, hardly any details were forthcoming, and only one locally active contact was identified. The proposed telephone or face-to-face interviews to explore the nature, level and quality of the PPI experience could, therefore, not be carried out. It may be that this contact was made at too late a stage in the trial, but the lack of responses more likely reflects the lack of PPI activity specifically linked to the VALID programme at local sites where groups often worked episodically on task-specific PPI activities.

Reflections/critical perspectives

The range of research activities to which PPI members can contribute is potentially extensive: from designing studies and developing grant applications to joining research management and governance committees, to reviewing research recruitment materials and process, to collecting and analysing data, and to disseminating research outcomes. It is important to recognise these opportunities as well as the diversity of PPI members in terms of their differing motivations to get involved, experiences and views, and time available to contribute. PPI members have knowledge and experience that is of value to the project at all stages and levels. It is, therefore, important to afford users the opportunity to feed into the project at all levels and stages throughout by providing the relevant introductions and opportunity to comment at all meetings. Despite awareness of this it can be hard to achieve, but ongoing review and dialogue did help improve this aspect of meetings organisation over time.

Reflecting on their experiences towards the end of the programme, PPI reference group members reported mixed experiences and views about their involvement. This variation appears to stem from the differing meetings and activities that they had each been involved in, not least working with different members of the research team, and perhaps from bringing different interests and motivations for becoming involved initially. Some felt better included, listened to and valued than others, and that their respective skills were utilised more than those of others. Researchers, therefore, need to be prepared to recognise that PPI colleagues will have varying experiences, perspectives and views to contribute, and so time needs to be given to enable these to be voiced, discussed and, where possible, considered. PPI members highlighted the need for the research team to provide clear information at the very start about the project, about what their role(s) within it would or could be and the time commitment required. It is especially important to bear in mind that some PPI colleagues are contributing in a voluntary capacity and often have other commitments for which sufficient time needs to factored in for them to respond. The research process itself was seen as being slow at points and so it was sometimes difficult to maintain momentum. The turnover of staff within the central research team was also seen to have hampered communication. Take-up of the various training opportunities offered, and the degree to which they were felt to have been useful, was experienced as mixed.

It was felt that much had been learned by PPI members and also by research team members over the course of the programme about current developments within the field of PPI, while also acknowledging that more contemporary PPI innovations might not have been fully incorporated, not least the changing terminology used to describe those involved. It is important that all those involved in the research recognise and respect the essential role that PPI members played and fully value the diversity of experience and views that this brings to the process.

There has clearly been an ongoing and active commitment to PPI demonstrated over the duration of the programme, starting at the grant application stage and planned to continue throughout the ongoing dissemination phase. This has primarily been achieved through the evaluative support of the VALID PPI reference group, which has consistently provided valued critical discussion and collaboration. The level and type of activity varied in response to the stage of the research programme, and as outlined above, other individuals and organisations have also contributed. We thank them all for their input.

Dissemination and impact strategy

A dissemination and impact strategy was developed and monitored by the principal investigators group and co-ordinated by the programme manager. Key objectives were to raise awareness of the programme among the general public, NHS and relevant organisations and research bodies, such as service commissioners, policy-makers, professional bodies and government bodies not only to secure the commitment of clinical services at the study sites, but also to establish relationships with relevant stakeholders and users of research. ‘Users’ of this research were identified as being people living with dementia and family carers, along with the organisations supporting and representing them, practitioners, service commissioners, and the academic community.

Peer-reviewed publications

For the full list of peer-reviewed publications arising from the programme, see Acknowledgements, Publications.

The professional impact to date of the peer-reviewed publications is demonstrated by the fact that one publication, by Swinson et al. 42 was one of the most frequently downloaded British Journal of Occupational Therapy papers in 2016 (and was available as open access for a limited time) and another, by Di Bona et al. ,40 was selected as the British Journal of Occupational Therapy ‘Editor’s Pick’ during the month of its publication, which meant that it was more actively promoted by the journal’s publisher.

Other dissemination activities

Additional dissemination activities are listed in Report Supplementary Material 1, including oral and poster presentations at international, national and local events for research, practitioner and lay audiences, as well as general media items.

Research outputs were submitted to the relevant NIHR programme manager for approval in line with the ‘28 day’ rule, reported as part of the annual reporting system, entered into ‘ResearchFish’ (research impact assessment platform),100 and circulated to research staff, collaborators and interested parties as relevant on publication.

Newsletter

A newsletter was produced twice per year with support from JH, and was circulated electronically to collaborators, academic and professional colleagues, interested individuals and organisations. It was sent electronically both in embedded e-mail format and as an attached PDF, with hard copies also available on request. A hard copy was sent to all research participants via their local research team.

Website

A website was set up to contain information about the programme for a professional and lay audience (www.ucl.ac.uk/valid), including research participants and collaborators, and was regularly updated by a research assistant within the central research team in conjunction with the lay co-applicant. The site included two secure sections – one for the occupational therapists involved in intervention delivery and one for research staff and collaborators – to facilitate access to the most up-to-date programme documents and materials. In reality, this latter aspect was not used as much as foreseen owing to numerous technological issues; for example, NHS staff were frequently dependent on different or outdated software provided within their organisations and were, therefore, not able to open or download the documents in the correct format. The website was hosted by UCL and, for this reason, needed to adhere to the UCL ‘house style’, not least to maintain the technical support required. For this reason, the site was sometimes seen as not being as ‘user-friendly’ in style as it could have been to more effectively engage a wide audience, including people with dementia and their supporters. However, the website has continued to be regularly accessed from across the world.

Social media

A Twitter account (@VALIDResearch) (Twitter, Inc., San Francisco, CA, USA; www.twitter.com) was established and had 122 followers as of January 2019. Activity was sporadic, with posts primarily being made when key programme milestones were reached, such as RCT recruitment, or to advertise dissemination activities, such as conference presentations or new publications. Guidelines on the safe and professional use of social media produced by UCL and the Royal College of Occupational Therapists were followed. Given that the use of social media has grown exponentially over the course of the programme, it is acknowledged that future research studies and personnel could make more regular and productive use of these opportunities to disseminate research progress, as well as support the recruitment of research participants.

Future dissemination and impact activities

The VALID PPI reference group will have a key role to play in planning the dissemination activities following the end of the programme. These will include producing a lay summary of the programme design and findings for circulation to all research participants, collaborators and other interested individuals and organisations. The group will also contribute to the planning and content of future dissemination events, the details of which are yet to be decided.

Post-doctoral research experience

The VALID programme provided postdoctoral experience for Jennifer Wenborn, a highly experienced occupational therapist, who used her combination of research and management skills to plan and co-ordinate a wide range of research activities in the role of programme manager. Sinéad Hughes, also an occupational therapist, gained postdoctoral research experience through completing a range of qualitative and quantitative activities during the development phase, and then of setting up a RCT, funded by the National Multiple Sclerosis Society (USA) before being appointed to a postdoctoral research fellowship based at the University of British Columbia, Canada. Nadia Crellin also gained trial management experience, before being appointed as programme manager for another NIHR-funded Programme Grants for Applied Research within the sponsor’s department.

Doctoral studies

Two research team members have been supported as part-time PhD students, both of whom have contributed to the VALID programme data collection, analysis and dissemination as part of their doctoral studies.

Becky Field, an occupational therapist and research associate at the Sheffield site, was registered as a part-time health services research PhD student in the School of Health and Related Research, University of Sheffield, and was awarded her PhD in summer 2020. Her study explored the take-up of psychosocial interventions by people with early-stage dementia and whether or not a readiness to engage in these interventions can be identified. The first phase included a secondary analysis of qualitative data collected through the semistructured interviews conducted with people with dementia and their family carers who had taken part in the COTiD intervention within the programme’s development phase (WP1). 101 Ethics approval for the above was obtained as a substantial and a non-substantial amendment to the VALID protocol. The second and main phase involved further empirical research, recruiting participants independently of VALID, and, therefore, has separate ethics and governance approval. In 2017, Becky Field was awarded the Early Researcher Award by the Royal College of Occupational Therapists for an oral presentation of her work at its annual conference, and in 2018 she received a Research Career Development Grant from the UK Occupational Therapy Research Foundation (UKOTRF) to continue her PhD studies.

Jacki Stansfeld, formerly a research assistant within the central research team (and now programme manager for another NIHR-funded Programme Grants for Applied Research multicentre RCT within the sponsor’s department), was registered as a part-time PhD student in the Division of Psychiatry, UCL, and was awarded her PhD in spring 2019. Her PhD study, ‘Sense of competence in family carers of people living with dementia: a positive psychology perspective’, seeks to understand the impact of positive aspects of caring on caregiver sense of competence in dementia. 102 Her study developed a new conceptual model of sense of competence in family caregivers of people living with dementia to advance the theoretical understanding of this construct to inform the development of appropriate clinical interventions to further support family carers in their role. This PhD used the VALID RCT baseline data (WP3 and WP4) alongside independently collected quantitative and qualitative data, and two systematic reviews, with three publications to date and more in preparation/planned. 103–105

There was also opportunity to collaborate with another doctoral research student, Holly Walton, a full-time PhD student registered at the Department of Clinical, Educational and Health Psychology at UCL, and funded by the UCL Economic and Social Research Council Doctoral Training Centre (Grant Reference: ES/J500185/1). Holly Walton completed her PhD at the end of 2018. As part of her work to develop a methodology and tools to assess the fidelity of an intervention being developed within another dementia research programme led by Martin Orrell, Holly Walton conducted two fidelity assessment studies embedded in the RCT (see Implementation phase). 89

Postgraduate studies

Two members of the central research team implemented aspects of the WP3 and WP4 protocol as part of their MSc courses. Jacqueline Mundy, trial manager and a registered nurse, carried out the qualitative study with family carers who had declined to participate in the RCT [see Chapter 5, Qualitative studies (work package 4)] for her part-time MSc in health service research at City, University of London, that was awarded with distinction in January 2018. 63 Jacqueline Mundy refined the indicative topic guide that had been previously been developed through a review of the literature, and obtained the relevant ethics and governance approvals needed for the additional recruitment documents required for this MSc project, as a substantial amendment to the RCT protocol.

Jane Burgess, an occupational therapist, joined the central research team on secondment from her substantive memory services clinical lead post as the COTiD-UK trainer and supervisor for WP3 and WP4. Jane Burgess completed a part-time MSc, in Dementia: Causes, Treatments and Research, at University College London in autumn 2019. She conducted six of the dyad qualitative interviews and led the thematic analysis of the dyad and occupational therapist interview data [see Chapter 5, Qualitative studies (work package 4)]. 62 She was subsequently recruited to a substantive research post, utilising her trial management and interventional research experience to contribute to or take on the role of local principal investigator for other portfolio studies within the sponsor’s department.

Laura Di Bona, an occupational therapist researcher at the Sheffield site, obtained funding to evaluate a care home pilot intergenerational scheme, which gained national interest, and more recently has been awarded research capacity funding to lead a project on peer support for her local NHS trust, as well as being the first occupational therapist to be accepted onto the School of Health and Related Research (ScHARR) clinical research academy.

Research experience for lay colleagues and occupational therapist participants

As noted above, two members of the PPI reference group (JH and DP) moved on to contributing as peer researchers for other dementia studies.

Alongside the more formal research student opportunities noted above, many practising occupational therapists have engaged in the research process through their participation in the development phase activities, such as recruiting and seeking informed consent from participants, collecting research data, delivering a manualised intervention, taking part in focus group and/or completing the online the survey, and/or delivering the COTiD-UK intervention within the RCT, thus increasing their research knowledge, skills and experience. Feedback from the occupational therapists has consistently been positive about the value of being able to contribute to the research to build the profession’s evidence base. There are several examples of these occupational therapist participants continuing their research involvement. For example, in Sheffield, some have since delivered the intervention within another RCT, and one has recently been seconded to the local research department through research capacity funding.

Jennifer Wenborn and another occupational therapist who took part in the development phase COTiD training and delivery were appointed as allied health professional research champions for their respective CRN areas. This collaboration between the NIHR and the Council for Allied Health Professions Research aims to build momentum and maximise the visibility and impact of allied health professionals in a research context, both locally and nationally. 106

Summary of the programme and outcomes

This applied research programme focused on the development and evaluation of a community occupational therapy intervention for people with mild to moderate dementia and their family carers. It built on the COTiD intervention that was developed and found to be clinically effective and cost-effective in the Netherlands. 23–25

The VALID research programme consisted of five WPs across three phases: (1) development of the UK version of the intervention, known as COTiD-UK (WP1 and WP2); (2) piloting and evaluation through an internal pilot and full RCT of COTiD-UK compared with TAU, along with an economic evaluation and two embedded qualitative studies (WP3 and WP4); and (3) implementation of COTiD-UK in practice (WP5), including assessment of the intervention delivery fidelity. In summary, the following outcomes were achieved.

A mixed-methods approach was taken in the development phase to translate, put into practice and adapt the COTiD intervention and training model and resources to maximise its suitability and feasibility for use within the UK culture and health and social care service context. This produced the UK version of the intervention, known as COTiD-UK.

The trial statistical results did not indicate any benefit of the COTiD-UK intervention compared with TAU for the outcomes selected. 48 The COTiD-UK intervention was assessed as being delivered within the RCT overall with moderate fidelity, albeit with variation between occupational therapists and sites. 89 Likewise, the economic evaluation did not find COTiD-UK to be cost-effective compared with TAU. This is in contrast to the qualitative study, with dyads describing the outcome of the intervention in very positive terms, and providing examples of how they had taken up activities they had not undertaken for a while and felt enabled to plan how they would continue their occupational participation in the future. 62 Over 90% of goals set by the dyads taking part in COTiD-UK were achieved. 48 The occupational therapists felt that COTiD-UK was ‘real OT’ and allowed them to utilise their unique core skills and expertise. 62

Inevitably, we encountered challenges while conducting this extensive research programme. The development phase took twice as long as originally scheduled. This was because of underestimating the time that the translation of the Dutch materials would take, and then a series of organisational challenges across the 10 sites at which occupational therapists were trained to put COTiD into practice. The piloting and evaluation phase was, therefore, delayed. The internal pilot was reviewed with the Independent PSC against the ACCEPT criteria, which agreed that the data collected to date could be carried forward into the main trial data set. 44 This pragmatic trial was conducted against a background of various organisational issues. Recruitment of sites took longer than scheduled, partly because it became necessary to recruit more sites than originally planned because the number of occupational therapists available at most sites was smaller and the dropout rate higher than expected. It was a complex study to conduct because it required sites to co-ordinate researcher capacity (researchers were often enlisted from local CRNs), and to recruit and collect data from dyads rather than individual participants, as well as ensure there was sufficient occupational therapist capacity to deliver the COTiD-UK intervention within the protocol time frame. This was particularly problematic because only 2 of the 12 trial sites managed to obtain excess treatment costs, which inevitably reduced the availability of occupational therapists at any point. This, therefore, led to delays in being able to recruit participants until therapists were available to provide the intervention within a timely manner following randomisation. The delivery of the intervention was, therefore, often dependent on the goodwill of the occupational therapists, their managers and their colleagues, who supported them to implement this alongside their usual practice and the need to continue delivering the usual commissioned services.

This was a well-run study and, to the best of our knowledge, is the largest RCT of occupational therapy for people with dementia and their family carers in the UK to date. The non-adherence rate of 4.6% and attrition rate of 13% at 26 weeks were both close to the 5% and 15% estimates, respectively, that we used to calculate the sample size, based on similar trials of other psychosocial interventions. 107,108

The ICC estimate is slightly higher than that used in the sample size calculation and the full sample size was not quite attained (97.5%). Despite this, the large p-value (0.55) obtained for a test of the null hypothesis of no difference in the BADLS total score between groups and a 95% CI (–0.85 to 1.51) covering zero from a large sample is not suggestive of an effect estimate that would have differed significantly from zero, had the intended sample size been attained.

It is recognised that in clinical trials there may be differences in the quantitative results and the qualitative findings. This may be more likely when psychosocial interventions deliver a rewarding and socially meaningful experience. It could, therefore, be suggested that the positive qualitative findings reflected the impact of receiving the face-to-face and personalised engagement, particularly if the local service provision did not usually include support for people at this stage of their dementia pathway. However, the outcomes that dyads reported were very occupationally focused, with reports of meaningful activities that had been dropped resuming and of new ones being established. It is unlikely that this would have happened purely through the social engagement within the COTiD-UK sessions.

The intervention fidelity was lower than that reported in the Graff study,23 which was a small trial involving only two occupational therapists, who were deeply committed and also closely monitored while delivering the intervention. This was a much larger trial, with 15 sites and 468 dyads, involving 32 occupational therapists with varying levels of prior clinical and COTiD-UK-specific expertise. However, the majority of the occupational therapists delivering the COTiD-UK intervention already had extensive experience of working with people living with dementia and family carers or working in the community.

Given the differences in the Dutch and English results, it is possible that the different settings in the Netherlands and the UK for the intervention delivery played a role. This is especially likely because usual care differed between the two countries. The Dutch control group did not receive any occupational therapy because occupational therapy was not provided in the community to people with dementia at that time.

By contrast, occupational therapy practice for people with dementia is well established within the UK. Over the course of this research programme, UK memory services became better established, and the policy impetus for earlier diagnosis and access to services means that more people receive some occupational therapy input at the mild to moderate stage of dementia. However, this is usually far less than the COTiD-UK intervention provides and is usually focused on just the person with dementia rather than being a dyadic intervention. 42 It primarily aims to inform the diagnostic process or assess/manage the person with dementia’s level of risk, and any input to family carers usually focuses on their ability to perform their role and tasks as a carer and not their own occupational needs, such as is the case with COTiD-UK. 42 Therefore, we acknowledge that the provision of occupational therapy within the TAU group inevitably varied between and within the participating research sites and, for this reason, was a variable that we could not control.

We feel that the difference with the Dutch results is unlikely to be accounted for by adapting the COTiD intervention or training programme. The COTiD-UK intervention retained the same core principles and components of the original COTiD intervention but is more flexible in its content and delivery; for example, the occupational therapists can use a wider range of assessment and intervention tools that are already in regular use within UK practice, and the time span for delivery is extended from 5 to 10 weeks to better meet the needs of pairs and be more feasible for service delivery. 42 We restructured the COTiD-UK training programme into 2 consecutive days followed by a third day once the therapists had put COTiD-UK into practice to be more cost-effective and feasible for services to release staff, and to better meet the needs of UK occupational therapists, many of whom already have extensive experience of working with people living with dementia or family carers or in the community.

Limitations

We collected data regarding social contact and leisure activities over the previous 12 weeks because we anticipated that these should increase as an outcome of the intervention. However, there were some problems with the quality of these data, partly because of dyads’ difficulty in recalling their activities accurately and partly owing to a lack of consistency in how this information was recorded by the researchers, despite training. This brings into question how accurate the results in this domain are.

We found that there was a very high rate of goal attainment; however, given the design, it was not feasible to ask people in the TAU group to set goals for comparison given that goal-setting is a key part of the intervention. The GREAT trial19 (Goal-orientated cognitive rehabilitation in early stage dementia) also found positive results for goal attainment, which was the primary outcome, but no difference between the treatment and the control groups on the validated secondary outcomes covering the conventional range of domains. Further complicating matters, the goals set with the GREAT participants at baseline were not shared with the therapist providing the intervention, who may then have worked on different goals altogether. We felt that asking people in the TAU group within this study to set goals may raise their expectations and optimism around success, and potentially lead to demoralisation when the goals are unfulfilled. Owing to the sample size and extended follow-up timescale, it was not feasible for us to offer the intervention to the TAU group on completion of all data collection as sometimes happens.

A further limitation is that the sample was not representative of the UK population in terms of ethnicity because most people included were white British. Nevertheless, this is not unusual in this kind of study, as it can be difficult to recruit other ethnic groups and fluency in English was part of the eligibility criteria. However, this was essential to enable data collection and the intervention to be provided on the basis of all providers and participants sharing similar levels of first language skills. It is possible that the nature of the dyadic relationship (spouse or parent-adult child) and living situation (living alone or together) may have impacted the intervention in terms of the type of goals set and how they were achieved. This study was not designed or powered to look at such individual differences, but from our experiences we had no reason to think there was any discernible impact from these factors. In addition, we did not collect data on social class, which may potentially have affected the dyads’ participation in the intervention, in that those with fewer resources available to them may find it more difficult to achieve their goals.

Implications for practice

The trial statistical results did not indicate any benefit of the COTiD-UK intervention, as delivered in this trial, compared with usual care for the outcomes measured. However, the qualitative findings indicated that the occupational therapists felt that COTiD-UK was ‘real OT’ and utilised their core unique skills, namely enhancing health and well-being through taking part in activity, and the dyads provided tangible examples of how they had resumed or taken up meaningful activities as a result of the sessions. There is no evidence to suggest that occupational therapy input in general does not continue to be a highly valued and important part of multiprofessional teamworking and service provision. The relatively well-developed occupational therapy practice for people with dementia in the UK provides a firm foundation for occupational therapists continuing to contribute to community teamwork and memory service provision for people with cognitive problems and their families.

Recommendations for future research

Traditionally, psychosocial intervention research has focused on measuring outcomes such as cognition, daily living abilities and quality of life because these are core domains potentially affected by dementia that these interventions seek to improve. The measures used were mostly developed for use within pharmacological studies and tended to focus on the level of deterioration and impairment. There are inherent difficulties in expecting improvements in ADL in someone with a progressive disorder such as dementia, despite conflicting findings in the Dutch study. In our study, we noted that, in the main, dyads set goals related to a wider range of activities than those covered by the BADLS, for example leisure, creative, social and community based.

Since the VALID programme started in 2012, there has been a growing focus on measuring outcomes in dementia research that are beyond simply the negative consequences, such as cognitive impairment and functional decline. For example, a number of positive psychology measures have been developed, which may help to better understand how people’s capabilities and self-management skills might be enhanced through training and goal-setting. 109 It is, therefore, important to develop tools and methods to measure outcomes of complex interventions, such as COTiD-UK, that truly reflect the occupational aim and nature of the intervention, as well as what is meaningful and prioritised by people with dementia and family carers rather than the traditional. Given that over 90% of goals set by the dyads taking part in COTiD-UK were fully or partially achieved and covered a much broader scope than traditional ADL activities, further analysis of the goals set and met could inform the future selection and development of more meaningful occupational outcome measures, tools and processes.

There is now a focus on developing patient-related outcomes in formats that make them suitable for self-report. This would enable data to be collected directly from people with dementia themselves rather than having to rely on proxy data from carers who can provide their own views only.

Conclusion

This study found no statistical evidence for the clinical effectiveness of COTiD-UK compared with the usual care provided, despite the perceived enthusiasm from the occupational therapists, people with dementia and family carers who took part. The programme of research was conducted to a very high standard of methodology with an independent PSC and a DMEC. The delivery of the COTiD-UK intervention achieved moderate fidelity, suggesting that people with dementia and family carers were receiving the sessions as planned and true to the goals and purpose of the intervention and study protocol. Having considered sources of bias, we found no particular reason to question the validity of our statistical results in relation to the clinical effectiveness and also the value for money of COTiD-UK.

We have shown that it is possible to conduct and effectively deliver a well-designed, high-quality, highly complex clinical trial of occupational therapy across 15 sites and requiring intervention delivery by experienced occupational therapists. This paved the way for demonstrating the potential feasibility of other large-scale trials in dementia.

Programme Steering Committee members

1. Dr Claire Ballinger (chairperson), University of Southampton.

2. Dr Christian Bottomley, London School of Hygiene and Tropical Medicine.

3. Professor Stephen Curran, South West Yorkshire Partnership NHS Foundation Trust (June 2013 to November 2015).

4. Dr Jane Fleming, Institute of Public Health, University of Cambridge.

5. Professor Priscilla Harries, Brunel University London.

6. Mrs Kate Harwood, lay member.

7. Mr Keith Oliver, lay member.

Data Monitoring and Ethics Committee members

1. Professor Jill Manthorpe (chairperson), King’s College London.

2. Dr Stephanie Daley, Brighton and Sussex Medical School.

3. Ms Jenny Helier, King’s College London.

4. Dr Rekha Elaswarapu, lay member.

5. Ms Jane Hopkins, lay member.

6. Ms Shamime Lakda, lay member.

Occupational Therapy Reference Group members

1. Sally Rooks (chairperson), North East London NHS Foundation Trust (November 2012 to 2018).

2. Sarah Bains, Derbyshire Healthcare NHS Foundation Trust (November 2012 to May 2014).

3. Carol Duff, Lincolnshire Partnership NHS Foundation Trust (May 2015 to 2018).

4. Julie Edwards, Sheffield Health and Social Care NHS Foundation Trust (November 2012 to 2018).

5. Joan Hansen, Tees, Esk and Wear Valleys NHS Foundation Trust (September 2014 to 2018).

6. David Heasman, South West London and St George’s Mental Health NHS Trust (November 2012 to September 2014).

7. Andy Lucas, Humber Centre for Forensic Psychiatry (November 2012 to 2018).

8. Alice Moody, 2gether NHS Foundation Trust (November 2012 to 2018).

9. Caroline O’Haire, North East London NHS Foundation Trust (November 2012 to November 2013).

10. Karin Orman, Royal College of Occupational Therapists (November 2012 to 2018).

11. Shirley Pearce, Royal College of Occupational Therapists Specialist Section – Older People, Dementia Forum Lead (September 2014 to 2018).

12. Pasna Sallis, Royal College of Occupational Therapists Specialist Section – Older People, Dementia Forum Lead (November 2012 to January 2014).

13. Jane Tuxworth, Lincolnshire Partnership NHS Foundation Trust (November 2012 to January 2014).

We particularly thank Karin Orman and the Royal College of Occupational Therapists for supporting this group and providing a venue for their meetings.

Patient and Public Involvement Reference Group members

1. Professor Fiona Poland (chairperson), University of East Anglia, VALID co-applicant, PPI lead.

2. Kate Harwood, lay member.

3. Jane Hill, lay member, VALID co-applicant.

4. David Prothero, lay member.

We also thank Dr Karen Harrison-Dening, and Joy Watkins (deceased) at Dementia UK for their support in recruiting PPI representatives to join the PSC and PMG; recruiting participants to contribute to the consensus event conducted in WP1; and being named as the independent contact on the relevant research participant information sheets.

We also thank the South Yorkshire Dementia Research Advisory Group for their useful comments regarding the participant recruitment materials produced for the evaluation phase.

This programme of research was hosted and sponsored by NELFT. We, therefore, thank our NELFT colleagues within the research and development department and clinical services for their continued support of the programme and research team.

The VALID research team acknowledge the support of the NIHR CRN.

We thank the Priment Clinical Trials Unit at UCL for their support in conducting the RCT.

Elena Pizzo and Stephen Morris were (in part) supported by the National Institute for Health and Care Research (NIHR) Collaboration for Leadership in Applied Health Research and Care North Thames at Bart’s Health NHS Trust. The views expressed are those of the author(s) and not necessarily those of the NHS, NIHR or Department of Health and Social Care.

We acknowledge the support of the UCLH NIHR Biomedical Research Centre.

Contributions of authors

Jennifer Wenborn (https://orcid.org/0000-0001-7311-8972) (Senior Clinical Research Associate – Occupational Therapist: Division of Psychiatry, University College London/Research & Development Department, North East London NHS Foundation Trust), as a co-applicant, contributed to the design and methodology of the research programme and was a PMG member. As programme manager, she co-ordinated all aspects of the programme delivery and managed the central research team in NELFT. She co-ordinated and contributed to the COTiD-UK development activities (WP1); contributed to the design and analysis of the online survey of occupational therapy practice (WP2). In WP3 and WP4 she was a member of the TMG, collected and analysed the qualitative data, trained and supervised the occupational therapists delivering COTiD-UK, and contributed to the economic evaluation and fidelity studies; she supported the PPI and OTRGs; co-ordinated the dissemination of the programme; and prepared the final report in collaboration with other co-authors.

Gail Mountain (https://orcid.org/0000-0002-5417-7691) [Professor of Applied Dementia Research: Centre for Applied Dementia Studies, University of Bradford/School of Health and Related Research (ScHARR), University of Sheffield], as a co-applicant, contributed to the design and methodology of the research programme and was a PMG member. She managed the Sheffield research centre; contributed to the COTiD-UK development activities (WP1); supervised the occupational therapists delivering COTiD-UK, and contributed to the trial delivery, qualitative design, fidelity study and implementation activities (WP5); and led the publication strategy.

Esme Moniz-Cook (https://orcid.org/0000-0002-7232-4632) (Professor of Clinical Psychology of Ageing and Dementia Care Research: Faculty of Health Sciences, University of Hull), as a co-applicant, contributed to the design and methodology of the research programme and was a PMG member. She managed the Humber research centre; contributed to the COTiD-UK development activities (WP1); trial recruitment and delivery (WP3 and WP4); and implementation activities (WP5).

Fiona Poland (https://orcid.org/0000-0003-0003-6911) (Professor of Social Research Methodology: School of Health Sciences, University of East Anglia), as a co-applicant, contributed to the design and methodology of the research programme and was a PMG member. She was the qualitative and PPI lead, contributed to the COTiD-UK development activities (WP1) and supervised the qualitative design and analysis.

Michael King (https://orcid.org/0000-0003-4715-7171) (Professor of Primary Care Psychiatry: Division of Psychiatry, University College London) as a co-applicant contributed to the design and methodology of the research programme and was a member of the PMG and TMG. He supervised the conduct of the RCT (WP3 and WP4).

Rumana Omar (https://orcid.org/0000-0003-1483-1932) (Professor of Statistics: Department of Statistical Science, University College London) as a co-applicant contributed to the design and methodology of the research programme and was a member of the PMG and TMG. She designed, supervised and validated the RCT statistical analysis (WP3 and WP4).

Aidan O’Keeffe (https://orcid.org/0000-0002-0776-0868) (Associate Professor of Statistics: Department of Statistical Science, University College London) was a member of the TMG, conducted the RCT statistical analysis and prepared the trial statistical report and anonymised data set.

Stephen Morris (https://orcid.org/0000-0002-5828-3563) (Professor of Health Economics: Department of Applied Health Research, University College London), as a co-applicant, contributed to the design and methodology of the research programme and was a PMG member. He designed and supervised the economic evaluation (WP1, WP3 and WP4). He is now RAND Professor of Health Services Research: Department of Public Health and Primary Care, University of Cambridge, UK.

Elena Pizzo (https://orcid.org/0000-0003-0790-7505) (Senior Research Associate – Health Economist: Department of Applied Health Research, University College London) conducted the economic evaluation (WP1, WP3 and WP4).

Susan Michie (https://orcid.org/0000-0003-0063-6378) (Professor of Health Psychology/Director: UCL Centre for Behaviour Change, Department of Clinical, Educational and Health Psychology, University College London), as a co-applicant, contributed to the design and methodology of the research programme and was a PMG member. She supervised the COTiD-UK fidelity study and contributed to the implementation activities (WP5).

Myrra Vernooij-Dassen (https://orcid.org/0000-0002-9746-9897) (Professor of Psychosocial Care for Frail Older Persons: Radboud University Medical Centre, Nijmegen, the Netherlands), as a co-applicant, contributed to the design and methodology of the research programme. She was a PMG member and contributed to the COTiD-UK adaptation, RCT and implementation activities.

Maud Graff (https://orcid.org/0000-0003-4361-4291) (Professor of Occupational Therapy: Radboud University Medical Centre, Nijmegen, the Netherlands) developed the original COTiD intervention in the Netherlands. She contributed to the COTiD-UK adaptation, RCT and implementation activities.

Jane Hill (https://orcid.org/0000-0001-9045-8012) (Writer and Former Carer), as a co-applicant, contributed to the design and methodology of the research programme and was a PMG member. She contributed her personal experience of caring for a person with dementia, and her professional writing skills to enhance the research participant recruitment materials and programme dissemination – website, newsletters and Plain language summary.

David Challis (https://orcid.org/0000-0002-6464-2286) (Professor of Community Care Research/Director: Personal Social Services Research Unit, University of Manchester), as a co-applicant, contributed to the design and methodology of the research programme and was a PMG member. He provided specialist advice on the development and evaluation of complex community interventions and the RCT design and analysis. He is now Professor of Community Care Research, Institute of Mental Health, University of Nottingham.

Ian Russell (https://orcid.org/0000-0002-0069-479X) (Professor of Clinical Trials: Medical School, Swansea University), as a co-applicant, contributed to the design and methodology of the research programme and was a PMG member. He provided specialist advice on the RCT design, methodology and analysis.

Catherine Sackley (https://orcid.org/0000-0002-8580-6622) (Professor of Physiotherapy/Head of Department: Public Health Sciences Research, King’s College London), as a co-applicant, contributed to the design and methodology of the research programme and was a PMG member. She provided specialist advice on the development and evaluation of complex community/occupational therapy interventions and the RCT design, methodology and analysis.

Sinéad Hynes (https://orcid.org/0000-0002-3199-7355) (Clinical Researcher – Occupational Therapist: North East London NHS Foundation Trust) contributed to the design, conduct and analysis of the COTiD-UK development activities (WP1); the design, conduct and analysis of the online survey (WP2), and was the trial manager July to October 2014. She is now Lecturer in Occupational Therapy: School of Health Sciences, National University of Ireland Galway, Ireland.

Nadia Crellin (https://orcid.org/0000-0002-9497-5874) (Postdoctoral Researcher: Research & Development Department, North East London NHS Foundation Trust/Division of Psychiatry, University College London) was the RCT trial manager October 2014 to January 2016. She is now research fellow at Nuffield Trust.

Jacqueline Mundy (https://orcid.org/0000-0001-7917-7041) (Research Nurse: Research & Development Department, North East London NHS Foundation Trust/MSc student: School of Health Sciences; City, University of London) was the trial manager from April 2016 to June 2018; designed and conducted the qualitative study that explored why people declined to take part in the RCT. She is now specialist stroke nurse at Essex Stroke Hub Team, North East London NHS Foundation Trust.

Jane Burgess (https://orcid.org/0000-0002-4626-6424) (Clinical Researcher – Occupational Therapist: Research & Development Department, North East London NHS Foundation Trust/MSc student: Division of Psychiatry, University College London) trained and supervised the occupational therapists delivering COTiD-UK; chaired the COTiD-UK supervisors group; oversaw the COTiD-UK delivery and COTiD-UK data collection and management; completed the COTiD-UK intervention data analysis; collected and analysed the qualitative data; and contributed to the fidelity study and implementation activities.

Tom Swinson (https://orcid.org/0000-0003-2314-9193) (Senior Research Assistant – Occupational Therapist: Research & Development Department, North East London NHS Foundation Trust) contributed to the COTiD-UK development activities (WP1); contributed to the design, conducted and analysed the online survey of occupational therapy practice (WP2); completed the COTiD-UK intervention data analysis (WP3 and WP4); contributed to the fidelity study; provided technical support to the occupational therapists delivering the occupational therapy intervention throughout the programme; and set up and edited the VALID website. He is now occupational therapist in Herts and Broxbourne Adult Disability Team, Hertfordshire County Council, Stevenage.

Laura Di Bona (https://orcid.org/0000-0002-5659-4368) (Research Associate – Occupational Therapist: School of Health and Related Research, University of Sheffield) contributed to the COTiD-UK development activities (WP1); trained and supervised the occupational therapists who delivered the COTiD-UK intervention; contributed to the qualitative data collection and analysis; and contributed to the implementation activities.

Becky Field (https://orcid.org/0000-0003-3502-2691) (Research Associate – Occupational Therapist/PhD student: School of Health and Related Research, University of Sheffield) contributed to the COTiD-UK development activities (WP1); managed trial recruitment at the Sheffield research site; and contributed to the implementation activities.

Cathryn Hart (https://orcid.org/0000-0003-3582-0685) (Assistant Director, Research & Development: Humber Teaching NHS Foundation Trust, Hull) managed the research team and RCT activities at the Humber site, and contributed to the multisite RCT conduct.

Jacki Stansfeld (https://orcid.org/0000-0002-4491-5523) (Senior Research Assistant: Research & Development Department, North East London NHS Foundation Trust/PhD student: Division of Psychiatry, University College London) contributed to the COTiD-UK development activities (WP1); contributed to the analysis of the online survey of occupational therapy practice (WP2); contributed to the RCT activities, including training research staff at other sites. She is now the RADAR (Research into Antipsychotic Discontinuation and Reduction) Programme Manager at North East London NHS Foundation Trust.

Holly Walton (https://orcid.org/0000-0002-8746-059X) (PhD student: Department of Clinical, Educational and Health Psychology, University College London) conducted the fidelity study. She is now research fellow in the Department of Applied Health Research, University College London.

Sally Rooks (https://orcid.org/0000-0002-5460-0146) (Clinical Lead Occupational Therapist: North East London NHS Foundation Trust), as a co-applicant, contributed to the design and methodology of the research programme, was a PMG member and chaired the independent OTRG. She contributed to the COTiD-UK development activities (WP1); the design, conduct and analysis of the online survey of occupational therapy practice (WP2); and the RCT trial conduct and occupational therapist qualitative data analysis.

Ritchard Ledgerd (https://orcid.org/0000-0001-5646-577X) (Dementia Clinical Lead: Research & Development Department, North East London NHS Foundation Trust) contributed to the COTiD-UK development activities (WP1); and contributed to the design, conduct and analysis of the online survey of occupational therapy practice (WP2).

Martin Orrell (https://orcid.org/0000-0002-1169-3530) (Director, Institute of Mental Health/Head, Division of Psychiatry and Applied Psychology, Faculty of Medicine & Health Sciences, University of Nottingham), as the lead applicant/chief investigator, supervised the design and methodology of all stages of the research programme, and chaired the PMG. He contributed to the development of COTiD-UK (WP1); supervised the design and analysis of the online survey of occupational therapy practice (WP2); chaired the TMG (WP3 and WP4); oversaw the revision of the implementation WP; contributed to programme dissemination in terms of publications and conference presentations; and oversaw the writing of the final report.

All authors contributed to dissemination of the programme. All authors provided a critical review and final approval of the report.

Publications

Burgess J, Wenborn J, Di Bona L, Orrell M, Poland F. Taking part in the community occupational therapy in dementia UK intervention from the perspective of people with dementia, family carers and occupational therapists: a qualitative study. Dementia (London) 2021;20:2057–76. https://doi.org/10.1177/1471301220981240

Di Bona L, Wenborn J, Field B, Hynes SM, Ledgerd R, Mountain G, Swinson T. Enablers and challenges to occupational therapists’ research engagement: a qualitative study. Br J Occup Ther 2017;80:642–50. https://doi.org/10.1177/0308022617719218

Field B, Mountain G, Burgess J, Di Bona L, Kelleher D, Mundy J, Wenborn J. Recruiting hard to reach populations to studies: breaking the silence: an example from a study that recruited people with dementia. BMJ Open 2019;9:e030829.

Hynes SM, Field B, Ledgerd R, Swinson T, Wenborn J, di Bona L, et al. Exploring the need for a new UK occupational therapy intervention for people with dementia and family carers: Community Occupational Therapy in Dementia (COTiD). A focus group study. Aging Ment Health 2016;20:762–9. https://doi.org/10.1080/13607863.2015.1037243

Mundy J, Stansfeld J, Orrell M, Cartwright M, Wenborn J. Reasons for nonparticipation in the Valuing Active Life in Dementia randomised controlled trial of a dyadic occupational therapy intervention: an interview study. SAGE Open Med 2020;8:1–12. https://doi.org/10.1177/2050312120958926

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Data-sharing statement

All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.

Disclaimers

This report presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, CCF, PGfAR or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the PGfAR programme or the Department of Health and Social Care.

Patient data

This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.