Home-based health promotion for older people with mild frailty (HomeHealth): intervention development and feasibility Randomised Controlled Trial

Abstract Background: Mild or pre-frailty is common yet potentially reversible. Preventing progression to worsening frailty may benefit individuals and lower health/social care costs. However, we know little about effective approaches to preventing frailty progression.Objectives: To develop an evidence and theory-based home-based health promotion intervention for older people with mild frailty.To test feasibility, costs and acceptability of the intervention, and of a full-scale clinical and cost-effectiveness Randomised Controlled Trial (RCT).Design: Evidence reviews, qualitative studies, intervention development, feasibility RCT with process evaluation.Intervention development: Two systematic reviews (including systematic searches of 14 databases and registries, 1990-2016 and 1980-2014), a state-of-the-art review (inception-2015) and policy review identified effective components for our intervention. We collected data on health priorities and potential intervention components from semi-structured interviews and focus groups with older people (n=44), carers (n=12) and health/social care professionals (n=27). These data, and our evidence reviews, fed into development of the ‘HomeHealth’ intervention in collaboration with older people and multi-disciplinary stakeholders. ‘HomeHealth’ comprised 3-6 sessions with a support worker trained in behaviour change techniques, communication skills, exercise, nutrition and mood. Participants addressed self-directed independence and wellbeing goals, supported through education, skills-training, enabling individuals to overcome barriers, providing feedback, maximising motivation and promoting habit formation.Feasibility RCT: Single-blind RCT, individually-randomised to ‘HomeHealth’ or Treatment-As-Usual (TAU).Setting: Community settings in London and Hertfordshire, United Kingdom. Participants: 51 community-dwelling adults aged 65years+ with mild frailtyMain outcome measures: Feasibility: recruitment, retention, acceptability, intervention costsClinical and health economic outcome data at 6 months included: Functioning, frailty status, well-being, psychological distress, quality of life, capability, NHS and societal service utilisation/costs.Results: We successfully recruited to target, with good 6 months retention (94%). Trial procedures were acceptable with minimal missing data. Individual randomisation was feasible. The intervention was acceptable, with good fidelity and modest delivery costs (£307/patient). 96% of participants identified at least one goal, mostly exercise-related (73%). We found significantly better functioning (Barthel Index; +1.68, p=0.004), grip strength (+6.48kg, p=0.02), reduced psychological distress (GHQ-12; -3.92, p=0.01) and increased capability-adjusted life years (+0.017; 95% CI 0.001 to 0.031) at 6 months compared to TAU, with no differences in other outcomes. NHS and carer-support costs were variable, but overall lower in the intervention arm. The main limitation was difficulty maintaining outcome assessor blinding.Conclusions: Evidence is lacking to inform frailty prevention service design, with no large-scale trials of multi-domain interventions. From stakeholder/public perspectives, new frailty prevention services should be personalised and encompass multiple domains, particularly socialising and mobility, and can be delivered by trained non-specialists. Our multi-component health promotion intervention was acceptable and delivered at modest cost. Our small study shows promise for improving clinical outcomes, including functioning and independence. A full-scale individually randomised RCT is feasible.Next steps: A large, definitive RCT of the HomeHealth service is warranted. Study registration: PROSPERO: CRD42014010370; Trials ISRCTN11986672 Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. XX, No. XX. See the NIHR Journals Library website for further project information.