Promoting Independence in Dementia (PRIDE): A Feasibility Randomized Controlled Trial
Received 9 September 2020
Accepted for publication 13 November 2020
Published 25 February 2021 Volume 2021:16 Pages 363—378
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Richard Walker
Emese Csipke,1 Aisha Shafayat,2 Kirsty Sprange,2 Lucy Bradshaw,2 Alan A Montgomery,2 Reuben Ogollah,2 Esme Moniz-Cook,3 Martin Orrell4
1Division of Psychiatry, University College London, London, UK; 2Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK; 3Faculty of Health Sciences University of Hull, Hull, UK; 4Institute of Mental Health, University of Nottingham, Nottingham, UK
Correspondence: Emese Csipke
Division of Psychiatry, University College London, 6th Floor, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK
Email [email protected]
Background: There is a need for interventions to foster and maintain independence for people with dementia to support community living, improve morale, and reduce stigma. We investigated a social intervention to promote living well and enhance independence for people with mild dementia.
Methods: In this two arm parallel group, feasibility RCT at six sites in England, participants were randomized (1:1) to the PRIDE intervention (encompassing social, physical, and cognitive domains supported by a facilitator over three sessions) compared to usual care only. The main objective was to determine the feasibility of a main trial with respect to measures of recruitment, retention, and adherence to the intervention.
Results: During a 7-month period, 402 people were invited to the trial, 148 were screened (37%, 95% confidence interval (CI)=32– 42%), 137 were eligible at pre-consent, 94 consented to the trial (69% of those eligible, 95% CI=60– 76%), and 92 were randomized (46 to each group). Of those allocated to the intervention, 42 (91%) received at least one of three intervention sessions. Outcome assessment follow-up visits were completed for 73 participants at 6 months (79%, 95% CI=70– 87%), and this was similar for both groups.
Conclusion: A large multi-center trial of the PRIDE intervention in community-dwelling people with mild dementia is feasible using systematic recruitment strategies. The intervention was successfully delivered and well received by participants. Findings from this study will be used to refine the design and processes for a definitive RCT.
Trial Registration: ISRCTN, ISRCTN11288961, registered on 23 October 2018.
Keywords: dementia, feasibility trial, randomized controlled trial, psychosocial intervention
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