Promoting Independence in Dementia (PRIDE): A Feasibility Randomized Controlled Trial

Abstract

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

Acknowledgments

We would like to acknowledge and thank the sponsor, The University of Nottingham, and the research sites and participants The authors would also like to thank the larger Pride team for their input: Holly Walton, Aimee Spector, Susan Michie, Eef Hogervorst, Linda Birt, Fiona Poland, Paul Higgs, Ula Htay, David Prothero, Thomas Stevens, Monica Panca, Jem Bhatt, Ruth Hacket, Hilary Davies, Snorri Rafnsson, and Reuben Ogollah, Lucy Bradshaw, and Samantha Beard at the Nottingham Clinical Trials Unit. Members of the independent Trial Steering Committee: Myrra Vernooij-Dassen, Yun-Hee Jeon, Bob Woods, and Rabih Chattat.

Data Sharing Statement

The datasets generated during and/or analyzed during the current study will be available upon reasonable request from Nottingham Clinical Trials Unit.

Email: [email protected] Telephone: [phone].

Ethical Approval

The study was approved by West Midlands – Solihull Research Ethics Committee (REC) (Ref: 18/WM/0281). Trial Registration: ISRCTN: 11288961.

Author Contributions

All authors made substantial contributions to the conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work.

Disclosure

Kirsty Sprange reports a grantfrom National Institute of Health Research (NIHR), during the conduct of the study. Martin Orrell reports grants from NIHR/ESRC, during the conduct of the study. The authors report no other potential conflicts of interest for this work.