Title: Individually randomised controlled multi-centre trial to determine the clinical and cost effectiveness of a home-based exercise intervention for older people with frailty as extended rehabilitation following acute illness or injury, including embedded process evaluation
Funder: Department of Health and Social Care

Abstract: DESIGN: Pragmatic, multi-centre (10 sites) RCT with two-level, partially nested hierarchical design, internal pilot and embedded process evaluation. SETTING: Recruitment from elderly medicine, trauma & orthopaedics wards in 10 UK hospitals across 2 hubs (Yorkshire/South West) and from linked intermediate care services. Participants randomised to the intervention (n=400) will complete a 24 week home-based exercise programme supported by a therapist trained in the HOPE manual. POPULATION: Older people with frailty admitted to hospital following acute illness or injury, and discharged home from hospital or from intermediate care. INCLUSION CRITERIA: Age>65; frailty (Clinical Frailty Scale (CFS) 5-7); mobility (complete Timed Up-and-Go Test, TUGT); capacity to give consent, or named consultee for assent willing to support intervention delivery; able to communicate via telephone. EXCLUSION CRITERIA: Permanent care home residents; moderate/severe dementia; severe stroke; unstable angina/recent MI; another household member in trial; severe frailty (CFS 8); terminally ill (CFS 9); palliative care; referral for disease specific rehabilitation; unable to complete TUGT. INTERVENTION: 24 week home-based exercise intervention (HOPE programme) delivered by community rehabilitation staff, + usual care. The HOPE intervention consists of 12 week HOPE programme (5 home visits & 7 telephone sessions) plus 12 further weekly telephone sessions. CONTROL: Unrestricted usual care provided by primary, community and social services. RANDOMISATION: Individually randomised via CTRU in a 1.25:1 allocation ratio, stratified by site; discharge setting; level of HOPE programme (level 1, 2, or 3); reason for admission (acute illness or injury). COSTS/OUTCOMES: Baseline assessment; follow-up at six & 12 months; routine GP, HES & ONS data. PRIMARY: SF36 physical component summary (PCS) at 12 months. SECONDARY: SF36 mental component summary (MCS); Barthel index; Nottingham Extended Activities of Daily Living (NEADL) index; EQ5D-5L; mortality; falls; new care home placement; hospital readmission; health/social care resource use; cost effectiveness; intervention adherence; patient experience. SAMPLE SIZE: 718 patients (318 control, 400 intervention) will provide 90% power, 5% significance, to detect minimum clinically important difference (MCD) of 3 points on SF36 PCS (SD 9.47), accounting for 25% loss to follow-up, and clustering in the intervention arm (20 cluster size, 0.03 ICC). ANALYSIS: Intention to treat, reported according to CONSORT. Primary analysis will compare mean SF36 PCS scores between groups using a random-effects heteroscedastic model. Cost effectiveness analyses will report differences in cost of service use between groups and ICERs using QALYs derived from i) EQ5D-5L and ii) SF36/SF6D (sensitivity analysis). INTERNAL PILOT: In 4 sites with progression criteria assessed at 6 months (provision & recruitment); 9 months (acceptability); 12 months (follow-up). Intervention provision assessed through participants receiving 1st home visit within 3 weeks; acceptability through retention of participants; follow-up through completion of primary outcome. Criteria for all: green = >80%; amber =<80% but > or equal to 65%; red = <65%. For recruitment: green = at least 4 pts/month/site; amber = <4 but > or equal to 2 pts/month/site; red = <2pts/month/site. RECRUITMENT: The recruitment target is 718 patients across 10 sites over a total of 23 months, with recruitment staggered to accommodate the internal pilot. TIMETABLE: Set-up 1-9m; recruitment 10-32m; internal pilot progression criteria assessed at 16m (provision/recruitment), 19m (acceptability), 22m (follow-up); follow-up 16-44m; data cleaning, analysis & reporting 45-51m. EXPERTISE: Clinical, community rehabilitation, trial expertise, statistics, health economics, qualitative, PPI

Lay abstract: Frailty is a condition that is common in older age. It develops because as we get older our bodies change, and can lose their inbuilt reserves. These changes mean that older people with frailty can experience sudden, dramatic changes in their health when they have an illness or injury. For example, an apparently minor illness such as an infection, or an injury such as a fracture, can cause an older person with frailty to become less mobile and unable to carry out day-to-day tasks. This can often result in admission to hospital, and a further period of immobility. This is a major problem because, in frailty, even short periods of immobility can cause muscles that are already weak to become even weaker, preventing movements such as getting out of a chair, getting out of bed, getting on and off the toilet and climbing stairs. Older people with frailty are therefore likely to need a period of rehabilitation to improve overall muscle strength and ability to carry out day-to-day tasks before returning home from hospital. In the NHS, around a third of older people with frailty are likely to return home after a brief period of rehabilitation on a hospital ward. A further third will need a period of rehabilitation in 'intermediate care', which is a range of community rehabilitation services provided either in a setting such as a community hospital, or at home. However, current guidelines recommend that intermediate care should be for a relatively short period of between 2 to 6 weeks. A large national audit shows that people discharged from intermediate care often do not feel ready to leave the service and research suggests that the initial improvement from this short period of rehabilitation may not be sustained in the longer-term. An important part of rehabilitation is progressive physical exercise. We have developed the Home-based Older People's Exercise (HOPE) programme, which is a home-based exercise intervention for older people with frailty. Participants follow an exercise manual that contains exercises to strengthen the important muscles required for movements such as getting out of a chair, getting out of bed, and climbing stairs, under the guidance of a physiotherapist. The HOPE programme was developed with considerable input from older people with frailty, including the design of the exercise manual, to make sure that it is meaningful and acceptable to users. We have tested the HOPE programme with frail older people in a pilot clinical trial and the results show that the HOPE programme is feasible and safe, with potential to improve mobility. Our proposal is to study the HOPE programme as extended rehabilitation for older people with frailty who have been discharged home from hospital or from intermediate care after illness or injury. Our earlier pilot trial recruited frail older people from the community, so in this study we first plan to test recruitment from hospital and intermediate care. We also plan to test if it is possible to collect follow-up data using postal questionnaires. If we are able to successfully recruit and follow up enough participants we will continue the study and recruit a much larger number so that we can find out with more certainty if the HOPE programme can improve quality of life for older people with frailty. We will also test whether the HOPE programme provides value for money, and study how it is provided in practice so that we can roll it out across the NHS if it is successful.

Research activity codes: 6.7 PHYSICAL
Health categories: GENERIC HEALTH RELEVANCE