MulTI-domain Self-management in Older People wiTh OstEoarthritis and Multi-Morbidities (TIPTOE)

BACKGROUND: The prevalence of osteoarthritis (OA) with multiple long term conditions (MLTC) increases with age. Half of adults aged over 60 years suffer with OA and 70% of these struggle with the additional impacts of MLTC. These individuals use health services extensively and often require costly surgical or hospital care. The effectiveness of recommended non-surgical and non-pharmacological treatments for OA is unknown in this population. AIMS: To test the clinical and cost effectiveness of a co-designed individualised OA self-management support intervention for promoting health related quality of life and reducing healthcare costs added to treatment as usual (TAU) in comparison to TAU. DESIGN: Randomised, single blind, multi-centre clinical trial with 6-month internal pilot, embedded health economic evaluation and mixed methods process evaluation. The internal pilot will determine progression to full effectiveness evaluation. TARGET POPULATION & SETTINGS: We will recruit 824 older adults aged 70+ with knee and/ or hip OA and at least one other long term condition such as; gastrointestinal, cardiovascular, frailty, widespread pain and/ or clinically diagnosed depression. Recruitment will take place across primary, community and secondary care and employ strategies to include those from diverse and under-represented populations. RANDOMISATION: Participants will be individually randomly allocated in a 1:1 ratio using a minimisation algorithm with a random element for age, gender, OA site and recruitment site. INTERVENTION: Participants and a friend, family member or carer will receive up to six individualised coaching sessions with healthcare practitioners (HP’s) trained in personalised self-management support and with knowledge of application to living well in the context of MLTC. They will have access to an accompanying co-designed book and resources. Coaching sessions will be in person (in the home or clinic) or via video call, depending on participant preference. This will be in addition to TAU. COMPARATOR: TAU OUTCOMES: Our primary outcome is health related quality of life. Other outcomes include self-efficacy for condition management, pain, sedentary behaviour, falls, depression and anxiety, healthcare use and costs and adverse events. Our primary endpoint will be at twelve months’ post randomisation. MIXED METHODS PROCESS EVALUATION: We will conduct interviews with participants, to evaluate contextual factors and potential mechanisms of impact. Intervention fidelity will be evaluated through interviews and against a checklist. DATA ANALYSIS: Quantitative, qualitative and health economic data will be evaluated. STUDY WITHIN A PROJECT. We will explore and address different recruitment pathways and the strategies and barriers to recruitment and retention in this population and other underserved groups. PATIENT & PUBLIC INVOLVEMENT (PPI): Our study design is informed by interviews with older people with OA and MLTC and carers. They have advised on (1) the need for a holistic individualised trans-professional intervention (2) options for increasing accessibility to the research and (3) recruitment pathways. TEAM: Experts in musculoskeletal, gerontology, self-management, routine data, statistics, health economics, nutrition, patient safety, physical activity and trial management. IMPACT: Potential for integration of personalised care contextualised to current and anticipated needs of an aging and diverse population.