Evidence map›Paper›PMID 38031132›Full record

ArticlePilot and feasibility studies2023

Self-directed versus peer-supported digital self-management programmes for mental and sexual wellbeing after acquired brain injury (HOPE4ABI): protocol for a feasibility randomised controlled trial.

Hayley Wright, Aimee Walker-Clarke, Avril Drummond, Lisa Kidd, Giles Yeates, Deborah Williams, David McWilliams, Wendy Clyne, Cain C T Clark, Peter Kimani and 1 more

Open access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 27% of its field
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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
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

11 authors at 6 institutions in 2 countries.

Hayley WrightCentre for Intelligent Healthcare, Coventry University, CV1 5FB, Coventry, England. hayley.wright@coventry.ac.uk.ORCID http://orcid.org/0000-0003-2199-8255
Aimee Walker-ClarkeCentre for Intelligent Healthcare, Coventry University, CV1 5FB, Coventry, England.
Avril DrummondQueen's Medical Centre, University of Nottingham, NG7 2UH, Nottingham, England.
Lisa KiddSchool of Health & Life Sciences, Glasgow Caledonian University, Glasgow, G4 0BA, Scotland.
Giles YeatesRippling Minds, Oxfordshire, UK.
Deborah WilliamsCentre for Intelligent Healthcare, Coventry University, CV1 5FB, Coventry, England.
David McWilliamsCentre for Intelligent Healthcare, Coventry University, CV1 5FB, Coventry, England.
Wendy ClynePeninsula Medical School, University of Plymouth, PL4 8AA, Plymouth, England.
Cain C T ClarkCentre for Intelligent Healthcare, Coventry University, CV1 5FB, Coventry, England.
Peter KimaniWarwick Medical School, University of Warwick, CV4 7AL, Coventry, England.
Andy TurnerCentre for Intelligent Healthcare, Coventry University, CV1 5FB, Coventry, England.
Intelligent Health (United Kingdom) · GBGlasgow Caledonian University · GBUniversity Hospitals Coventry and Warwickshire NHS Trust · GBUniversity of Nottingham · GBUniversity of Plymouth · GBUniversity of Warwick · GB

Funding

Research for Patient Benefit Programme NIHR203600
6 · The paper itself

Abstract

backgroundAcquired brain injury (ABI) can lead to biopsychosocial changes such as depression, low self-esteem and fatigue. These changes can cause, and be caused by, sexual issues affecting relationships and wellbeing. Given the relationship between sexual wellbeing and mental health, it is feasible that supporting sexual wellbeing will benefit psychological wellbeing. However, neurorehabilitation is inconsistent and often fragmented across the UK, and psychological, sexual and social support are lacking. Research shows that self-management and peer-support programmes can improve quality of life, self-efficacy and psychological wellbeing after brain injury. This protocol describes a feasibility randomised controlled trial (RCT) of a digital self-management programme to support mental and sexual wellbeing (known as HOPE4ABI), co-designed with and for people with ABI.

methodsThis mixed-methods feasibility RCT has two parallel trial arms of the 8-week digital HOPE4ABI self-management programme. Eligibility criteria include age > 18 years, diagnosed or suspected ABI > 3 months prior to trial entry, access to an Internet-enabled device and ability to engage with the intervention. Referrals to the study website will be made via the National Health Service (NHS), social media and partnering organisations. Sixty eligible participants will be randomised at a ratio of 1:1 to peer-supported (n = 30) or self-directed (n = 30) HOPE4ABI programmes. Primary feasibility outcomes include recruitment and retention rates, engagement, adherence and usage. Secondary outcomes related to standardised measures of quality of life, sexual wellbeing and mental wellbeing. Participants and peer facilitators will be interviewed after the course to assess acceptability across both trial arms. DISCUSSION: This feasibility trial data is not sufficiently powered for inferential statistical analyses but will provide evidence of the feasibility of a full RCT. Quantitative trial data will be analysed descriptively, and participant screening data representing age, ethnicity and gender will be presented as proportions at the group level. These data may indicate trends in reach to particular demographic groups that can inform future recruitment strategies to widen participation. Progression to a definitive trial will be justified if predetermined criteria are met, relating to recruitment, retention, engagement and acceptability.

trial registrationISRCTN46988394 registered on March 1, 2023.

Indexed as

Brain injuryDigital health interventionFeasibilityPeer supportPsychosocial wellbeingSelf-managementSexual wellbeing

Identifiers

PMID38031132
PMCPMC10685616
OpenAlexW4389146930

What OpenQuestion holds

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LicenceCC BY
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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.