Community Occupational Therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID]) study: A single-blind, randomised controlled trial.

Jennifer Wenborn,David Challis,Martin Orrell,Elena Pizzo,Ian Russell,Maud Graff,Fiona Poland,Aidan G O’Keeffe,Jane Burgess,Gail Mountain,Stephen Morris,Nadia Crellin,Michael King,Catherine Sackley,Tom Swinson,Susan Michie,Jacki Stansfeld,Jacqueline Mundy,Rumana Omar ,Esme Moniz‐Cook ,Sinéad M Hynes ,Myrra Vernooij‐Dassen

doi:10.1371/journal.pmed.1003433

Abstract

We aimed to estimate the clinical effectiveness of Community Occupational Therapy for people with dementia and family carers-UK version (Community Occupational Therapy in Dementia-UK version [COTiD-UK]) relative to treatment as usual (TAU). We hypothesised that COTiD-UK would improve the ability of people with dementia to perform activities of daily living (ADL), and family carers' sense of competence, compared with TAU. The study design was a multicentre, 2-arm, parallel-group, assessor-masked, individually randomised controlled trial (RCT) with internal pilot. It was conducted in 15 sites across England from September 2014 to January 2018. People with a diagnosis of mild to moderate dementia living in their own home were recruited in pairs with a family carer who provided domestic or personal support for at least 4 hours per week. Pairs were randomised to either receive COTiD-UK, which comprised 10 hours of occupational therapy delivered over 10 weeks in the person with dementia's home or TAU, which comprised the usual local service provision that may or may not include standard occupational therapy. The primary outcome was the Bristol Activities of Daily Living Scale (BADLS) score at 26 weeks. Secondary outcomes for the person with dementia included the following: the BADLS scores at 52 and 78 weeks, cognition, quality of life, and mood; and for the family carer: sense of competence and mood; plus the number of social contacts and leisure activities for both partners. Participants were analysed by treatment allocated. A total of 468 pairs were recruited: people with dementia ranged from 55 to 97 years with a mean age of 78.6 and family carers ranged from 29 to 94 with a mean of 69.1 years. Of the people with dementia, 74.8% were married and 19.2% lived alone. Of the family carers, 72.6% were spouses, and 22.2% were adult children. On randomisation, 249 pairs were assigned to COTiD-UK (62% people with dementia and 23% carers were male) and 219 to TAU (52% people with dementia and 32% carers were male). At the 26 weeks follow-up, data were available for 364 pairs (77.8%). The BADLS score at 26 weeks did not differ significantly between groups (adjusted mean difference estimate 0.35, 95% CI -0.81 to 1.51; p = 0.55). Secondary outcomes did not differ between the groups. In total, 91% of the activity-based goals set by the pairs taking part in the COTiD-UK intervention were fully or partially achieved by the final COTiD-UK session. Study limitations include the following: Intervention fidelity was moderate but varied across and within sites, and the reliance on primarily proxy data focused on measuring the level of functional or cognitive impairment which may not truly reflect the actual performance and views of the person living with dementia. Providing community occupational therapy as delivered in this study did not improve ADL performance, cognition, quality of life, or mood in people with dementia nor sense of competence or mood in family carers. Future research should consider measuring person-centred outcomes that are more meaningful and closely aligned to participants' priorities, such as goal achievement or the quantity and quality of activity engagement and participation. Current Controlled Trials ISRCTN10748953.

Highlights

Personalised interventions provided to people with dementia and their family carers either separately or together can improve family carers’ well-being, delay admission to care homes, and reduce the risk of institutionalisation by up to one-third [1,2,3]
We found no statistical evidence that Community Occupational Therapy in Dementia (COTiD)-UK gave more benefit to people with dementia or their carers than the usual care provided in terms of the people with dementia being able to carry out activities or their mood or quality of life nor their family carers’ sense of competence or mood
We used a linear mixed effects model to compare the COTiD-UK and treatment as usual (TAU) groups on the total Bristol Activities of Daily Living Scale (BADLS) score at week 26 adjusting for site and baseline total BADLS score; we included a random effect to account for clustering by occupational therapist in the COTiD-UK arm and estimated separate variance parameters for the Community Occupational Therapy for people with dementia and their family carers pair-level error terms in COTiD-UK and TAU arms, owing to the more flexible nature of this model compared to that where a common variance parameter would be assumed for both arms

Summary

Introduction

Personalised interventions provided to people with dementia and their family carers either separately or together can improve family carers’ well-being, delay admission to care homes, and reduce the risk of institutionalisation by up to one-third [1,2,3]. The integral process evaluation highlighted the need to translate and to adapt complex interventions to the local context for evaluation and cross-national comparison to be effective [9] These contrasting findings showed the need for a large multisite RCT of COTiD compared with usual care before it could be adopted into practice in the United Kingdom. Our adaptations included the following: retaining the 10 hours of intervention but extending the length of delivery to 10 weeks, with individual session length being flexible so as to maximise the achievement of the goals set (for example, to accommodate activities being completed in the community that may take longer than 1 hour) and using a wider range of validated assessment tools in line with usual UK practice This produced the “Community Occupational Therapy in Dementia–UK version” (COTiD-UK) in readiness for evaluation through an RCT, as part of a funded programme of research “Valuing Active Life in Dementia” (VALID). We hypothesised that COTiD-UK would improve the ability of people with dementia to perform activities of daily living (ADL), and family carers’ sense of competence, compared with TAU

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Results

Conclusion