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Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Dementia | Study protocol

Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial

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

Published in: Trials | Issue 1/2019

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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.
Appendix
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Metadata
Title
Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial
Authors
Aisha Shafayat
Emese Csipke
Lucy Bradshaw
Georgina Charlesworth
Florence Day
Phuong Leung
Esme Moniz-Cook
Alan A. Montgomery
Steve Morris
Gail Mountain
Reuben Ogollah
Kirsty Sprange
Lauren Yates
Martin Orrell
Publication date
01-12-2019
Publisher
BioMed Central
Keywords
Dementia
Dementia
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3838-x

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