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

Author:

Wenborn Jennifer1ORCID,Mountain Gail2ORCID,Moniz-Cook Esme3ORCID,Poland Fiona4ORCID,King Michael5ORCID,Omar Rumana5ORCID,O’Keeffe Aidan5ORCID,Morris Stephen6ORCID,Pizzo Elena6ORCID,Michie Susan7ORCID,Vernooij-Dassen Myrra8ORCID,Graff Maud8ORCID,Hill Jane9ORCID,Challis David10ORCID,Russell Ian11ORCID,Sackley Catherine12ORCID,Hynes Sinéad13ORCID,Crellin Nadia9ORCID,Mundy Jacqueline9ORCID,Burgess Jane1ORCID,Swinson Tom9ORCID,Di Bona Laura14ORCID,Field Becky14ORCID,Hart Cathryn15ORCID,Stansfeld Jacki1ORCID,Walton Holly7ORCID,Rooks Sally9ORCID,Ledgerd Ritchard9ORCID,Orrell Martin16ORCID

Affiliation:

1. Division of Psychiatry, University College of London, London, UK

2. Centre for Applied Dementia Studies, Faculty of Health Studies, University of Bradford, Bradford, UK

3. Faculty of Health Sciences, University of Hull, Hull, UK

4. School of Health Sciences, University of East Anglia, Norwich, UK

5. Priment Clinical Trials Unit, University College London, London, UK

6. Department of Applied Health Research, University College London, London, UK

7. University College London Centre for Behaviour Change, Department of Clinical, Educational and Health Psychology, University College London, London, UK

8. Radboud University Medical Centre (Radboudumc), Nijmegen, the Netherlands

9. Research and Development Department, North East London NHS Foundation Trust, London, UK

10. Personal Social Services Research Unit, Faculty of Medical and Human Sciences, University of Manchester, Manchester, UK

11. Medical School, Swansea University, Swansea, UK

12. Department of Public Health Sciences, King’s College London, London, UK

13. School of Health Sciences, National University of Ireland Galway, Galway, Ireland

14. School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK

15. Humber Teaching NHS Foundation Trust, Hull, UK

16. Institute of Mental Health, University of Nottingham, Nottingham, UK

Abstract

Background People with dementia find it increasingly difficult to carry out daily activities (activities of daily living), and may require increasing support from family carers. Researchers in the Netherlands developed the Community Occupational Therapy in Dementia intervention, which was delivered in 10 1-hour sessions over 5 weeks to people with dementia and their family carers at home. Community Occupational Therapy in Dementia was found to be clinically effective and cost-effective. Objectives Translate and adapt Community Occupational Therapy in Dementia to develop the Community Occupational Therapy in Dementia - the UK version intervention and training programme and to optimise its suitability for use within the UK. To estimate the clinical effectiveness and cost-effectiveness of Community Occupational Therapy in Dementia - the UK version for people with mild to moderate dementia and their family carers compared with treatment as usual. Design The development phase used mixed methods to develop Community Occupational Therapy in Dementia - the UK version: translation, expert review, and adaptation of the manual and training materials; training occupational therapists; focus groups and interviews, including occupational therapists, managers, people with dementia and family carers; consensus conference; and an online survey of occupational therapists to scope UK practice. A multicentre, two-arm, parallel-group, single-blind individually randomised pragmatic trial was preceded by an internal pilot. Pairs were randomly allocated between Community Occupational Therapy in Dementia - the UK version and treatment as usual. A cost–utility analysis, fidelity study and qualitative study were also completed. Setting Community services for people with dementia across England. Participants People with mild to moderate dementia recruited in pairs with a family carer/supporter. Interventions Community Occupational Therapy in Dementia - the UK version is an activity-based, goal-setting approach for people with dementia and family carers, and is delivered at home by an occupational therapist for 10 hours over 10 weeks. Treatment as usual comprised the usual local service provision, which may or may not include standard occupational therapy. Main outcome measures Data were collected through interviews conducted in person with dyads at baseline and at 12 and 26 weeks post randomisation, and then over the telephone with a reduced sample of just carers at 52 and 78 weeks post randomisation. The primary outcome was the Bristol Activities of Daily Living Scale at 26 weeks. The secondary outcomes were as follows: person with dementia – cognition, activities of daily living, quality of life and mood; carer – sense of competence, quality of life and mood; all participants – social contacts, leisure activities and serious adverse events. Results The Community Occupational Therapy in Dementia manual and training materials were translated and reviewed. In total, 44 occupational therapists were trained and delivered Community Occupational Therapy in Dementia to 130 pairs. A total of 197 occupational therapists completed the survey, of whom 138 also provided qualitative data. In total, 31 people attended the consensus conference. Community Occupational Therapy in Dementia - the UK version has more flexibility than Community Occupational Therapy in Dementia in terms of content and delivery; for example, occupational therapists can use the wider range of assessment tools that are already in regular use within UK practice and the time span for delivery is 10 weeks to better meet the needs of pairs and be more feasible for services to deliver. In total, 31 occupational therapists provided Community Occupational Therapy in Dementia - the UK version within the randomised controlled trial. A total of 468 pairs were randomised (249 pairs to Community Occupational Therapy in Dementia - the UK version, 219 pairs to treatment as usual). People with dementia ranged in age from 55 to 97 years (mean 78.6 years), and family carers ranged in age from 29 to 94 years (mean 69.1 years). The majority of those with dementia (74.8%) were married; 19.2% lived alone. Most family carers (72.6%) were spouses but 22.2% were adult children. At 26 weeks, 406 (87%) pairs remained in the trial, and the Bristol Activities of Daily Living Scale total score did not differ at the 5% level when comparing groups (adjusted mean difference estimate 0.35, 95% confidence interval –0.81 to 1.51; p = 0.55). The adjusted (for baseline Bristol Activities of Daily Living Scale total score and randomised group) intracluster correlation coefficient estimate at week 26 was 0.043. There were no significant differences in secondary outcomes. At 52 and 78 weeks, there were no differences between the two groups in Bristol Activities of Daily Living Scale total score and secondary outcomes. The probability that Community Occupational Therapy in Dementia - the UK version is cost-effective at a threshold of willingness to pay per quality-adjusted life-year of £20,000 is 0.02%. In the qualitative interviews, participants reported positive benefits and outcomes. Of the 249 pairs allocated to Community Occupational Therapy in Dementia - the UK version, 227 reached the goal-setting phase, and 838 of the 920 goals set (90.8%) were fully or partially achieved. Limitations The development phase took longer than estimated because of translation time and organisational delays in delivering the intervention. Recruitment to the randomised controlled trial took longer than expected. Fidelity overall was moderate, with variation across sites and therapists. It is possible that Community Occupational Therapy in Dementia - the UK version did not work well in the UK service model in which usual care differs from that in the Netherlands. Conclusions This programme used a rigorous process to develop Community Occupational Therapy in Dementia - the UK version but found no statistical evidence of clinical effectiveness or cost-effectiveness compared with usual care. Qualitative findings provided positive examples of how Community Occupational Therapy in Dementia - the UK version had enabled people to live well with dementia. Future work Developing tools to measure more meaningful outcomes, such as goals achieved or the quantity and quality of activity participation, with less reliance on proxy data, to collect the views and experiences of people with dementia themselves. Trial registration This trial was registered as ISRCTN10748953 (WP3 and WP4). Funding This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 11, No. 5. See the NIHR Journals Library website for further project information.

Funder

National Institute for Health and Care Research

Publisher

National Institute for Health and Care Research

Subject

Public Health, Environmental and Occupational Health,Health Informatics,Health Policy

Reference109 articles.

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