Affiliation:
1. Coventry University
2. University of Nottingham School of Medicine
3. Glasgow Caledonian University School of Nursing Midwifery and Community Health: Glasgow Caledonian University School of Health and Life Sciences
4. Oxford Brookes University
5. University Hospitals Coventry and Warwickshire NHS Trust
6. University of Plymouth
7. Warwick Medical School: University of Warwick Medical School
Abstract
Abstract
Background
Acquired brain injury (ABI) can lead to biopsychosocial changes such as depression, low self-esteem, and fatigue 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 inadequate across the UK, and psychological, sexual, and social support is 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.
Methods
This mixed-methods feasibility RCT has two parallel trial arms of the 8-week digital HOPE4ABI self-management programme. Eligibility criteria includes: age > 18 years, sustained an ABI > 3 months prior to trial entry, access to internet enabled device, and ability to engage with the intervention. Referrals to the study website will be made via 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 programme. Primary feasibility outcomes include recruitment and retention rates, engagement, adherence, and usage. Secondary outcomes relate 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 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 group level. This data may indicate trends in reach to particular demographic groups that may 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 Registration
ISRCTN46988394 registered on 1st March 2023.
Publisher
Research Square Platform LLC
Reference63 articles.
1. Balogun B, Woodhouse J, Powell T, Long R, Beard J, Kennedy S et al. Acquired Brain Injury [Internet]. 2020 [cited 2021 Jun 8]. Available from: https://researchbriefings.files.parliament.uk/documents/CDP-2020-0026/CDP-2020-0026.pdf.
2. All-Party Parliamentary Group (APPG) on Acquired Brain Injury and United Kingdom Acquired Brain Injury Forum (UKABIF). Acquired Brain Injury and Neurorehabilitation, Time for Change [Internet]. 2018 [cited 2021 Jun 16]. Available from: https://cdn.ymaws.com/ukabif.org.uk/resource/resmgr/campaigns/appg-abi_report_time-for-cha.pdf.
3. Stroke Association. Stroke statistics [Internet]. [cited 2021 Jun 16]. Available from: https://www.stroke.org.uk/what-is-stroke/stroke-statistics.
4. Estimated societal costs of stroke in the UK based on a discrete event simulation;Patel A;Age Ageing
5. Time for change in acquired brain injury;Menon DK;Lancet Neurol