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

Shafayat, Aisha; Csipke, Emese; Bradshaw, Lucy; Charlesworth, Georgina; Day, Florence; Leung, Phuong; Moniz-Cook, Esme; Montgomery, Alan A.; Morris, Steve; Mountain, Gail; Ogollah, Reuben; Sprange, Kirsty; Yates, Lauren; Orrell, Martin

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 3 and 6 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 3 to 6 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: ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

Citation

Shafayat, A., Csipke, E., Bradshaw, L., Charlesworth, G., Day, F., Leung, P., Moniz-Cook, E., Montgomery, A. A., Morris, S., Mountain, G., Ogollah, R., Sprange, K., Yates, L., & Orrell, M. (2019). Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial. Trials, 20(1), Article 709. https://doi.org/10.1186/s13063-019-3838-x

• Journal Article Type: Article
• Acceptance Date: Oct 24, 2019
• Online Publication Date: Dec 11, 2019
• Publication Date: 2019-12
• Deposit Date: Oct 25, 2019
• Publicly Available Date: Dec 12, 2019
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 20
• Issue: 1
• Article Number: 709
• DOI: https://doi.org/10.1186/s13063-019-3838-x
• Keywords: Dementia; Self-management; Feasibility trial
• Public URL: https://nottingham-repository.worktribe.com/output/2962172
• Publisher URL: https://link.springer.com/article/10.1186%2Fs13063-019-3838-x
• Additional Information: Received: 7 August 2019; Accepted: 23 October 2019; First Online: 11 December 2019; : The study was approved by West Midlands - Solihull Research Ethics Committee (REC) (Ref: 18/WM/0281). As a non-pharmacological intervention this is not covered by the Medicines for Human Use (Clinical Trials) Regulations 2004. All participants will receive oral and written information about the trial and must give their written informed consent before enrolment. Participants are free to withdraw at any time.; : Not Applicable.; : The authors declare that they have no competing interests.
• Contract Date: Oct 31, 2019