Title: Individually randomised controlled multi-centre trial to determine the clinical and cost effectiveness of an adapted yoga programme for older adults with multimorbidity, including an embedded process evaluation
Funder: Department of Health and Social Care

Abstract: Aim: To determine the clinical and cost effectiveness of the Gentle Years Yoga programme plus usual care versus usual care only in community-dwelling older adults with multimorbidity_x000D_ _x000D_ Background and rationale: Multimorbidity is common in older adults, and associated with high levels of illness burden and healthcare expenditure. The evidence base for how best to manage older adults with multimorbidity is weak. Yoga might be a useful intervention, because it is low cost, simple, and can address several health conditions simultaneously. Gentle Year Yoga (GYY) is a yoga programme that was developed for older adults with chronic conditions. A pilot trial of GYY demonstrated feasibility and encouraging preliminary data. A full-scale trial is needed to determine clinical and cost effectiveness._x000D_ _x000D_ Design: Pragmatic individually-randomised controlled trial with process evaluation and economic analysis of cost effectiveness_x000D_ _x000D_ Setting: The intervention will be delivered in non-medical community-based facilities in at least 12 sites across England, Wales and Scotland_x000D_ _x000D_ Participants: The study aims to recruit 586 participants primarily via mail-out from general practices. Eligible participants will be aged 65 or over, community-dwelling, and with multimorbidity, defined as having two or more chronic conditions from a predefined list._x000D_ _x000D_ Interventions: Participants will be allocated either to a group that receives usual care and the offer of a 12-week GYY programme (n=293) or to a group that receives usual care only (n=293). The GYY programme will involve weekly group-based sessions and self-managed yoga practice on most days. Usual care will comprise unrestricted care from primary, secondary, community and social services._x000D_ _x000D_ Outcomes: Outcomes will be collected at baseline, and 3, 6 and 12 months after randomisation using self-report postal questionnaires. The primary outcome will be health-related quality of life measured using the EQ-5D-5L; the primary endpoint being the overall difference over 12 months. Secondary outcomes will include anxiety, depression, activities of daily living, falls, and healthcare resource use. Adherence to the intervention will be assessed using class registers and self-report. _x000D_ A process evaluation will be conducted to provide understanding of trial delivery, intervention implementation, and the perspectives of targeted participants._x000D_ An economic evaluation will be undertaken from the perspectives of (a) NHS and personal social services (PSS) and (b) society. In a cost-consequences analysis we will relate the cost of the intervention or usual care to changes in a range of outcomes. In a cost-effectiveness analysis from the NHS and PSS perspective we will estimate the incremental cost per QALY gain. Uncertainty will be addressed in sensitivity analyses and by using bootstrapping to estimate the net monetary benefit and a cost-effectiveness acceptability curve._x000D_ _x000D_ Sample size: Accounting for 20% attrition, a sample size of 586 will provide 90% power to detect a standardised mean difference of 0.3 for the EQ-5D-5L at the 2-sided 5% significance level_x000D_ _x000D_ Potential impact: There is widespread interest in how to improve care for patients with multimorbidity. If successful, this intervention could improve the quality of life of patients and reduce NHS and patient costs. Through the work of the process evaluation, we will ensure that if the intervention is effective, it can be implemented widely, quickly and effectively.

Lay abstract: Aim: We will address the NIHR Themed Call on Complex Health and Care Needs in Older People, with a focus on Theme 4: promoting healthy ageing/preventing ill health._x000D_ _x000D_ We propose a randomised controlled trial in 12 sites across the UK to understand the health effects and cost effectiveness of a 12-week yoga programme adapted for older adults who have complex health needs._x000D_ _x000D_ NIHR defines complex health needs as the presence of more than one health or social care need (impacting on health) as well as a depth of need in terms of the severity of the conditions or intensity of the needs. The definition of multimorbidity adopted is the existence of two or more chronic health disorders in one individual._x000D_ _x000D_ The Need: One of the biggest challenges facing healthcare is the presence of complex health needs in the rapidly expanding older population. Research studies have shown that people with complex health needs are more likely to have reduced physical function, quality of life and life expectancy and increased mental health concerns. The more health problems someone has the more likely they are to consult a GP, be prescribed drugs and be admitted to hospital. Treatments associated with long-term health conditions account for 70% of NHS expenditure. Guidelines highlight that further research is needed to identify cost-effective treatments for this patient group._x000D_ _x000D_ The proposed benefits of regular yoga practice are wide-ranging, including increased strength, flexibility, balance and quality of life, and reduced stress, anxiety and depression. Research suggests that yoga may improve physical function and quality of life in older people, but little work has been done to understand the effects of yoga in older people with complex health needs._x000D_ _x000D_ Background: A 2016 pilot study of the British Wheel of Yoga (BWY) Gentle Years Yoga© programme was conducted with 52 older adults (average age 75). Adaptations to common yoga poses were developed so that inactive older adults with long-term conditions such as osteoarthritis, high blood pressure and dementia could safely participate in and reap the benefits of chair-based yoga. Recruitment was easy. The study showed that yoga could be a potentially useful treatment for improving mobility as well as mental and social wellbeing. It is simple, cheap, non-invasive, and can benefit several health conditions._x000D_ _x000D_ Public Involvement: Most of the participants continued in the classes on a self-pay basis after the pilot ended, which confirmed that they found the programme to be of value. They have been actively involved in the proposed trial’s plans and they are committed to continuing their support and help with the project._x000D_ _x000D_ Methods: The trial will recruit 586 adults aged 65 years or over who have more than one long-term condition. After initial assessments, participants will be allocated either to a group that receives usual care and a 12-week yoga programme (involving weekly group-based sessions and self-managed home practice) or a group that receives usual care only. Participants will complete questionnaires after 3, 6 and 12 months to assess their progress. This will involve assessments of quality of life and mental health. Some participants and yoga tutors will be interviewed to determine their experiences of the programme and study processes._x000D_ _x000D_ Dissemination: The research findings will be written up in journal publications and evidence briefings, and presented at various forums and conferences.

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