Clinical and cost-effectiveness of a personalised health promotion intervention enabling independence in older people with mild frailty (‘HomeHealth’) compared to treatment as usual: study protocol for a randomised controlled trial

Frost, Rachael; Avgerinou, Christina; Goodman, Claire; Clegg, Andrew; Hopkins, Jane; Gould, Rebecca L.; Gardner, Benjamin; Marston, Louise; Hunter, Rachael; Manthorpe, Jill; Cooper, Claudia; Skelton, Dawn A.; Drennan, Vari M.; Logan, Pip; Walters, Kate

Abstract

Background: Frailty is clinically associated with multiple adverse outcomes, including reduced quality of life and functioning, falls, hospitalisations, moves to long-term care and mortality. Health services commonly focus on the frailest, with highest levels of need. However, evidence suggests that frailty is likely to be more reversible in people who are less frail. Evidence is emerging on what interventions may help prevent or reduce frailty, such as resistance exercises and multi-component interventions, but few interventions are based on behaviour change theory. There is little evidence of cost-effectiveness.

Previously, we co-designed a new behaviour change health promotion intervention (“HomeHealth”) to support people with mild frailty. HomeHealth is delivered by trained voluntary sector support workers over six months who support older people to work on self-identified goals to maintain their independence, such as strength and balance exercises, nutrition, mood and enhancing social engagement. The service was well received in our feasibility randomised controlled trial and showed promising effects upon outcomes.

Aim: To test the clinical and cost-effectiveness of the HomeHealth intervention on maintaining independence in older people with mild frailty in comparison to treatment as usual (TAU).

Methods: Single-blind individually randomised controlled trial comparing the HomeHealth intervention to TAU. We will recruit 386 participants from general practices and the community across three English regions. Participants are included if they are community-dwelling, aged 65+, with mild frailty according to the Clinical Frailty Scale. Participants will be randomised 1:1 to receive HomeHealth or TAU for 6 months. The primary outcome is independence in activities of daily living (modified Barthel Index) at 12 months. Secondary outcomes include instrumental activities of daily living, quality of life, frailty, wellbeing, psychological distress, loneliness, cognition, capability, falls, carer burden, service use, costs and mortality. Outcomes will be analysed using linear mixed models, controlling for baseline Barthel score and site. A health economic analysis and embedded mixed-methods process evaluation will be conducted.

Discussion: This trial will provide definitive evidence on the effectiveness and cost-effectiveness of a home-based, individualised intervention to maintain independence in older people with mild frailty in comparison to TAU, that could be implemented at scale if effective.

Citation

Frost, R., Avgerinou, C., Goodman, C., Clegg, A., Hopkins, J., Gould, R. L., …Walters, K. (2022). Clinical and cost-effectiveness of a personalised health promotion intervention enabling independence in older people with mild frailty (‘HomeHealth’) compared to treatment as usual: study protocol for a randomised controlled trial. BMC Geriatrics, 22(1), Article 485. https://doi.org/10.1186/s12877-022-03160-x

• Journal Article Type: Article
• Acceptance Date: May 24, 2022
• Online Publication Date: Jun 4, 2022
• Publication Date: Jun 4, 2022
• Deposit Date: May 24, 2022
• Publicly Available Date: Jun 6, 2022
• Journal: BMC Geriatrics
• Electronic ISSN: 1471-2318
• Publisher: Springer Science and Business Media LLC
• Peer Reviewed: Peer Reviewed
• Volume: 22
• Issue: 1
• Article Number: 485
• DOI: https://doi.org/10.1186/s12877-022-03160-x
• Keywords: Geriatrics and Gerontology
• Public URL: https://nottingham-repository.worktribe.com/output/8220589
• Publisher URL: https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-022-03160-x
• Additional Information: Received: 11 March 2022; Accepted: 24 May 2022; First Online: 4 June 2022; : ; : The study has been approved by the Health Research Authority Social Care Research Ethics Committee (ref 20/IEC08/0013). All participants will provide informed written or verbal consent to participate in this study. Written consent is prioritised as the preferred method of consent, however when carrying out remote baseline assessments, if written consent is not practical audio recorded verbal consent will be used. For verbal consent, each line of the consent form is read out and the participant verbally indicates agreement or disagreement (if an optional item, such as consent for being approached for further research). Recorded consent is retained as source data for consent and a transcript of the consent is sent to the participant and their GP. These procedures were put in place to mitigate the effects of the pandemic on the trial and were outlined to and approved by the ethics committee.; : Not applicable.; : Professor Claire Goodman is a NIHR Senior Investigator. Professor Dawn Skelton is a Director of Later Life Training Ltd, a not-for-profit Company that delivers training to health and fitness professionals working in exercise with older people. This includes training in the Otago Exercises (which form part of the exercise intervention in HomeHealth). Professor Pip Logan is a NIHR Senior Investigator. All other co-authors declare no conflict of interest.