Walking exercise behaviour-change in people with intermittent claudication: A multi methods research programme including the MOtivating Structured walking Activity in Intermittent Claudication (MOSAIC2) randomised controlled trial.

Question Can we refine and evaluate the clinical effectiveness, cost-effectiveness, and implementability of Motivating Structured walking Activity in people with Intermittent Claudication (MOSAIC2), a home-based walking behaviour-change intervention for people with Peripheral Artery Disease (PAD), in primary care and community services. Background PAD is a major public health issue, disproportionately affecting people with diabetes, socioeconomically deprived populations, and South Asian, African Caribbean, and Eastern European ethnic minority groups. Supervised exercise is recommended for people with PAD and intermittent Claudication (IC). Yet, limited NHS exercise provision means people are often advised to go home and walk . Despite advice, completion of self-directed walking is poor, because adopting a new, painful behaviour is counterintuitive and challenging without support. We demonstrated in an efficacy trial, that a home-based walking exercise behaviour-change intervention including hospital physiotherapist support called Motivating Structured walking Activity in people with Intermittent Claudication (MOSAIC1) improved walking capacity (6-minute walk distance) in people with IC. Aim To refine and evaluate the clinical effectiveness, cost-effectiveness, and implementability of MOSAIC2, a home-based walking exercise behaviour-change intervention delivered by multidisciplinary healthcare and non-traditional healthcare exercise providers, in primary care and community services. Objectives Refine MOSAIC2 with patients and providers to increase effectiveness, inclusivity, and implementation in primary care and community services Refine MOSAIC2 provider training with patients and providers for delivery by multidisciplinary healthcare and non-traditional healthcare exercise providers Conduct a feasibility study to assess MOSAIC2 fidelity of delivery, acceptability, implementation factors, inclusivity and data collection methods Conduct a trial to assess the effectiveness and cost-effectiveness of MOSAIC2 Conduct a multi-method process evaluation to inform the co-design of an implementation and sustainability strategy Maximise inclusive research throughout the research programme Build research capacity in an underrepresented discipline Methods 6-workstream research programme. Workstream 1-2: Co-refinement of MOSAIC2 and provider training for delivery in primary care and community services by multidisciplinary healthcare and non-traditional healthcare exercise providers. Workstream 3: A non-randomised feasibility study including 6 sites, 32 participants and 12 providers. Workstream 4: Two-arm randomised controlled trial including 24 diverse sites, 370 participants and 48 providers with internal pilot and health economic evaluation. Workstream 5: process evaluation and co-design of implementation strategy. Workstream 6: Cross-cutting research inclusivity workstream, supported by two community engagement officers from our underserved communities. Timelines A 63-month programme from September 2025. 9-months co-refinement, 11-months feasibility study, 34-months trial (including 9-months internal pilot, 18-months recruitment, 12-months follow-up), 9-months analysis and dissemination. 4-year part-time PhD fellowship. Impact and dissemination If effective and cost effective, MOSAIC2 will improve the health and care of people of PAD. We will make recommendations for MOSAIC2 implementation in primary care and community services. We will build research capacity in underrepresented disciplines. We will mobilise research progress and findings via social media, stakeholder meetings and public engagement events with the public, practitioners, and NHS service planners. We will work with charity and community organisations to reach our underserved communities. We will disseminate via international conferences and journals to reach academic experts.