VALID WPs 3/4: Pilot trial and RCT of COTiD-UK
Research type
Research Study
Full title
Valuing Active Life in Dementia (VALID) Work Packages 3/4: a pilot trial and randomised controlled trial of Community Occupational Therapy in Dementia (COTiD-UK)
IRAS ID
152356
Contact name
Martin Orrell
Contact email
Sponsor organisation
North East London NHS Foundation Trust
Research summary
Valuing Active Life in Dementia (VALID) is a five year research programme funded by the National Institute for Health Research (NIHR) [RP-PG- 0610-10108]. The programme aims to develop, evaluate and put into practice, an occupational therapy intervention for people with mild to moderate dementia and their family carers living in the community. It builds on the work of Graff and colleagues in The Netherlands that led to the development of the Community Occupational Therapy in Dementia intervention (COTiD). COTiD was found to be clinically and cost effective and has potential to be of benefit within the UK, but needs to be amended to maximise its usefulness within the UK context. Five Work Packages (WPs) cover four phases: development (WPs 1/2), pilot trial (WP3), randomised controlled trial [RCT] (WP4), and Implementation (WP5). The first phase of this programme (WPs 1/2) developed the COTiD-UK which is now ready to evaluate. This study comprises Work Packages 3 and 4.
WP 3 is a pilot trial to: field test the measures and procedures; and to finalise the intervention delivery, training and supervision; to be used in WP4. WP4 is a multisite randomised controlled trial (RCT) to test the clinical and cost effectiveness of COTiD-UK in comparison with treatment as usual (TAU). In total, 480 dyads (a person with dementia and their family carer); will be recruited and randomly allocated to EITHER receive the COTiD-UK intervention (ten, one hour occupational therapy sessions delivered in the person with dementia’s home), OR, to continue with their usual care (TAU). Outcome measures will be completed at baseline, then at: 12, 26 and 52 weeks, with the first 40% of the participants also completing a 78 week follow-up. Qualitative data will also be collected through interviews and observation of COTiD-UK sessions.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
14/LO/0736
Date of REC Opinion
14 Jul 2014
REC opinion
Further Information Favourable Opinion