Evidence map›Paper›PMID 41162859›Full record

Trial reportBMC medical research methodology2025

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.

T M Oh, S Batool, C Musicha, L Greene, H Wheat, L Smith, S Griffiths, A Gude, L Weston, H Shafi and 10 more

Abstract readRandomized Controlled TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medical research methodology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Informed Consent for Pediatric Lyme Meningitis Study: In-Person Versus Remote Approach.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

T M OhCommunity and Primary Care Research Centre, University of Plymouth, Plymouth, UK. tomasina.oh@plymouth.ac.uk.
S BatoolSocial Care and Society, University of Manchester, Manchester, UK.
C MusichaMedical Statistics, University of Plymouth, Plymouth, UK.
L GreeneCommunity and Primary Care Research Centre, University of Plymouth, Plymouth, UK.
H WheatCommunity and Primary Care Research Centre, University of Plymouth, Plymouth, UK.
L SmithCommunity and Primary Care Research Centre, University of Plymouth, Plymouth, UK.
S GriffithsCommunity and Primary Care Research Centre, University of Plymouth, Plymouth, UK.
A GudeCommunity and Primary Care Research Centre, University of Plymouth, Plymouth, UK.
L WestonCommunity and Primary Care Research Centre, University of Plymouth, Plymouth, UK.
H ShafiSocial Care and Society, University of Manchester, Manchester, UK.
K StevensMedical Statistics, University of Plymouth, Plymouth, UK.
C SutcliffePeninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.
W TaylorSocial Care and Society, University of Manchester, Manchester, UK.
W IngramPeninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.
B HussainCommunity and Primary Care Research Centre, University of Plymouth, Plymouth, UK.
P ClarksonSocial Care and Society, University of Manchester, Manchester, UK.
I SherriffCommunity and Primary Care Research Centre, University of Plymouth, Plymouth, UK.
O C UkoumunneNIHR Applied Research Collaboration South West Peninsula (PenARC), University of Exeter, Exeter, UK.
S CreanorPeninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.
R ByngCommunity and Primary Care Research Centre, University of Plymouth, Plymouth, UK.

Funding

National Institute for Health and Care Research D-PACT RP-PG-0217-20004
6 · The paper itself

Abstract

backgroundComplex 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.

methodsConsent 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.

resultsPre-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.

conclusionsWhile 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 registrationISRCTN80204146.

Indexed as

COVID-19DementiaInformed ConsentPatient SelectionPrimary Health CareAgedAged, 80 and overEnglandFeasibility StudiesFemaleHumansMaleSARS-CoV-2CapacityClinical trialConsentCOVID-19DementiaDementia PersonAlised Care Team (D-PACT)In-person consentPrimary careRecruitment challengesRemote consent

Identifiers

PMID41162859
PMCPMC12573961

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.