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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

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Authors

AISHA SHAFAYAT Aisha.Shafayat@nottingham.ac.uk
Research Facilitation Manager

Emese Csipke

Georgina Charlesworth

Florence Day

Phuong Leung

Esme Moniz-Cook

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit

Steve Morris

Gail Mountain

REUBEN OGOLLAH REUBEN.OGOLLAH@NOTTINGHAM.AC.UK
Associate Professor of Medical Statistics and Clinical Trials

Lauren Yates

MARTIN ORRELL M.ORRELL@NOTTINGHAM.AC.UK
Director - Institute of Mental Health



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., …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 Mar 28, 2024
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.