ORCID

Abstract

Background: Complex socio-cultural, psychological, geographical, and service-related challenges are faced when recruiting people with dementia for clinical trials. The aim of Phase 1 of the Dementia PersonAlised Care Team (D-PACT) project was to assess the feasibility of recruiting (identifying, approaching and consenting) people with dementia, including those without capacity to consent, to a cluster randomized controlled trial of a primary care-based personalized dementia support intervention in England. COVID-19 necessitated a shift to remote working, creating the opportunity to compare recruitment strategies before and under lockdown constraints. This paper shares the adaptations made to enable remote consent and capacity judgement with people with dementia, as well as lessons learned. Methods: Consent was conducted in person from September 2019 to March 2020. Remote consent was implemented from September 2020 to March 2021 after an enforced pause. Both quantitative and qualitative data were collected. Recruitment rates (proportion consented from eligible patients approached), mean monthly consent rates, and time spent on consent-related activities (tasks before and after consent/capacity-judgment meetings, miscellaneous tasks, travel) were compared. Participant experiences with remote recruitment were examined through thematic analysis of qualitative interviews. Results: Pre-COVID-19, 22 participants (9.9%) out of 228 approached were consented in person. During the pandemic, 19 participants (9.6%) out of 198 were consented remotely, excluding 15 participants initially approached pre-pandemic and later consented via remote means. Mean monthly consent rates increased from 3.6 (in person) to 5.6 (remote). However, remote consent required more time (mean 14 researcher-hours per participant vs. 9 in person), with 75% of time spent on consent-related tasks compared to 20% in person. Travel accounted for 40% of in-person consent time. Interviews (n = 13) showed general acceptability of remote processes. However pre-consent information was perceived as excessive and led some participants to skim materials, potentially reducing understanding. Conclusions: While remote consent is time-intensive, it achieves comparable rates (proportion consented/total approached) to in-person methods and higher monthly consent rates. A flexible, hybrid approach can enhance participation, offer choice, and increase person-centredness. Realistic planning for time and resources is crucial for inclusive dementia research. Funders should support these needs to ensure effective recruitment. Trial registration: ISRCTN80204146.

Publication Date

2025-10-30

Publication Title

BMC Medical Research Methodology

Volume

25

Issue

1

Acceptance Date

2025-09-18

Deposit Date

2025-12-22

Keywords

Capacity, Clinical trial, Consent, COVID-19, Dementia, Dementia PersonAlised Care Team (D-PACT), In-person consent, Primary care, Recruitment challenges, Remote consent, Humans, England, Male, Dementia/therapy, Feasibility Studies, Informed Consent/statistics & numerical data, Patient Selection, SARS-CoV-2, COVID-19/epidemiology, Aged, 80 and over, Female, Primary Health Care, Aged

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