# Comparing in-person and remote consent of people with dementia into a primary care-based cluster randomised controlled trial: lessons from the Dementia PersonAlised Care Team (D-PACT) feasibility study

## TL;DR

This study compares in-person and remote recruitment methods for dementia patients in a UK trial, finding that remote methods can be as effective but require more time.

## Contribution

The study introduces a feasible remote consent process for dementia patients, including those without capacity, during the pandemic.

## Key findings

- Remote consent achieved similar recruitment rates to in-person methods but required more time per participant.
- Interviews showed remote processes were generally acceptable but information overload was a concern.
- A hybrid recruitment approach is recommended to improve inclusivity and person-centered care in dementia research.

## Abstract

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.

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.

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.

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.

ISRCTN80204146.