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

Walters, Kate, Frost, Rachael, Kharicha, Kalpa, Avgerinou, Christina, Gardner, Benjamin, Ricciardi, Federico, Hunter, Rachael, Liljas, Ann, Manthorpe, Jill, Drennan, Vari, Wood, John, Goodman, Claire, Jovicic, Ana and Iliffe, Steve (2017) Home-based health promotion for older people with mild frailty (HomeHealth) : intervention development and feasibility Randomised Controlled Trial. Health Technology Assessment, 21(73), ISSN (print) 1366-5278

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 frailty Main outcome measures: Feasibility: recruitment, retention, acceptability, intervention costs Clinical 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.

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