Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial

Abstract

Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/Design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at three and six month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at three to six months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so will provide data to inform the design and conduct of a future trial. Trial Registration and protocol version ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019 Keywords Dementia, self-management, feasibility trial

Designing meaningful dementia care

“…One explanation for this is that the team experienced unanticipated national research governance changes. They planned three recruitment pathways: selfreferral, Join Dementia Research (JDR), and NHS recruitment (Shafayat et al, 2019). NHS recruitment was by far the most successful one.…”

“…The included quote from one facilitator "On one occasion I had to scrap everything and pull it right back, because we thought too big" illustrates the difficulties of running a pragmatic psychological intervention trial, where facilitator supervision is not standardized. In the PRIDE study, measures were taken to maximize fidelity to the intervention, including all facilitators attending the same training but nonetheless for 47% of deliveries for which fidelity was recorded, and it was below 75% (Shafayat et al, 2019).…”