Title: Clinical and cost-effectiveness of a personalised health promotion intervention enabling independence in older people with mild frailty (‘HomeHealth’): A Randomised Controlled Trial
Funder: Department of Health and Social Care

Abstract: Why are we doing this research?_x000D_ As we get older, we may develop a number of health conditions that affect how we feel and our ability to manage without help. For some of us it can mean we start to become frail, with less energy, appetite and muscle strength and find it harder to do household tasks such as shopping or cooking. Few health services exist to help prevent things getting worse. _x000D_ We worked with older people, health/social care workers, voluntary sector, policy-makers and experts to design a new service, 'HomeHealth' to support older people to maintain their current lifestyle and activities they enjoy. We then tested the service with 51 older people, and offered 6 home visits over 6 months. We focused on helping people find ways that could reduce the impact of feeling tired, low or anxious, poor appetite, memory concerns, weakness or low muscle strength. The service was liked, showed potential to help people stay independent and feel better, was of modest cost and merited a larger study (trial)._x000D_ _x000D_ What are we proposing to do?_x000D_ We aim to test if HomeHealth helps older people who are becoming frail stay independent for longer and provides value for money if offered as part of standard NHS care. _x000D_ We will trial (test) the service with 386 people aged 65 or more, registered with General Practices in London, Yorkshire and Hertfordshire. We will invite those as described above and who are struggling with household tasks. Participants will be allocated to one of two groups randomly; a group that receives the HomeHealth service in addition to any existing support, or a group that continues to get usual support only. The HomeHealth group will receive up to 6 home visits from a trained support worker who will help them set goals around staying well and healthy and work with them to identify what is going well, and address things causing difficulty (e.g. low energy, weakness, low mood). In our earlier study many people chose to work on improving their muscle strength or walking ability, feeling less low or lonely, or helping them make their home more suitable. We will follow up those taking part for a year, to see if they are able to look after themselves without further help, measure their health and wellbeing, e.g. muscle strength, and what services they use. We will then compare the two groups and see if HomeHealth helps people stay independent and well, and if the benefits outweigh its costs. _x000D_ Older people with relevant experience (JH and RE) were key partners in our earlier study and the design of HomeHealth. They are keen to stay involved and with a third older person (MKB) will help ensure this wider trial of HomeHealth reflects older people’s wishes and meets their needs. We are also consulting with the voluntary sector, health and social care practitioners._x000D_ _x000D_ How will we make a difference?_x000D_ This will be the first large study to test a new health promotion approach for older people who are starting to become frail that has been designed with and for the NHS. If it works and is value for money, it could be commissioned and used across the UK. We will set up a working group, with NHS, Local Authorities, Voluntary Sector and public advisors, to ensure that if HomeHealth is effective, it is used. They will support us in writing commissioning guidelines and policy briefing documents. We will arrange a parliamentary launch and work with key decision-makers and organisations such as NHS England.

Lay abstract: Background: Addressing complex needs in older people is challenging for NHS and social care. Current services focus on those with highest levels of need/frailty, but can be expensive, with mixed outcomes. We know little on clinically and cost-effective interventions for people with mild frailty._x000D_ _x000D_ Aim: To test clinical and cost-effectiveness of the HomeHealth intervention on maintaining independence in older people with mild frailty._x000D_ _x000D_ Design: Single-blind individually randomised controlled trial of the HomeHealth intervention compared to Treatment As Usual (TAU). Embedded process evaluation._x000D_ _x000D_ Setting: General Practices in diverse areas of London, Yorkshire & Hertfordshire._x000D_ _x000D_ Target population: Older people 65+ years with mild frailty defined using the Clinical Frailty Scale._x000D_ Exclusion criteria: Those in care homes, receiving palliative care, who lack capacity, already case-managed (e.g. by community teams)._x000D_ _x000D_ HomeHealth Intervention: Theory/evidence-based co-designed behaviour change health promotion intervention, supporting older people to work on goals to maintain independence, addressing factors (e.g. weakness) impacting on capability, opportunity and motivation. This includes physical activity/balance and strength exercises, nutrition, mood and enabling social engagement, individually tailored._x000D_ _x000D_ Outcomes: Primary: Functioning Activities of Daily Living (modified Barthel Index (BI)). Secondary: Instrumental Activities of Daily Living; quality of life; frailty phenotype (gait speed, grip strength, physical activity, exhaustion, weight loss/low BMI); wellbeing; psychological distress; loneliness; falls; cognition; capability; service use; costs; mortality._x000D_ _x000D_ Sample size: To detect a 1.85 point difference on the BI at 12 months with 90% power and 5% significance, assuming a SD of 5 and 20% attrition, total sample size is 386._x000D_ _x000D_ Analysis: The primary outcome will be analysed by intention-to-treat using mixed effects linear regression, with a random effect for therapist and controlling for baseline BI score. Secondary outcomes will be analysed with analogous linear or logistic regressions._x000D_ _x000D_ Economic analysis: We will calculate mean incremental cost per quality adjusted life year and years full of capability gained for the duration of the trial and report this from perspectives of the NHS, personal and social care services. A budget impact analysis will quantify costs to health and social care providers._x000D_ _x000D_ Process evaluation: We will undertake a mixed-methods process evaluation exploring fidelity, dose and reach of the intervention, potential mechanisms, contextual factors and pathways to impact. This includes semi-structured interviews (n~40) with a purposive sample of participants, service providers and stakeholders, using normalisation process theory to understand implementation and barriers and facilitators. Interviews will be recorded, transcribed and thematically analysed. We will assess fidelity from audio-recordings of intervention appointments and explore mechanisms/pathways to impact including goals selected, goal attainment, intervention effects stratified by behavioural target(s) and impact on behavioural outcomes._x000D_ _x000D_ Impact: This will test a new proactive health promotion service for older people with mild frailty. Our approach is designed to enable rapid implementation within diverse settings.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: GENERIC HEALTH RELEVANCE