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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

Authors

Aisha Shafayat

Emese Csipke

Lucy Bradshaw

Georgina Charlesworth

Florence Day

Phuong Leung

Professor Esme Moniz-Cook E.D.Moniz-Cook@hull.ac.uk
Professor of Clinical Psychology of Ageing and Dementia Care Research/ Dementia Research Work Group Lead

Alan A. Montgomery

Steve Morris

Gail Mountain

Reuben Ogollah

Kirsty Sprange

Lauren Yates

Martin Orrell



Abstract

© 2019 The Author(s).
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.

Journal Article Type Article
Publication Date Dec 11, 2019
Journal Trials
Print ISSN 1745-6215
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 20
Article Number 709
APA6 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, https://doi.org/10.1186/s13063-019-3838-x
DOI https://doi.org/10.1186/s13063-019-3838-x

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Copyright Statement
© The Author(s). 2019



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