Development of a digitalised complex intervention to promote activity of older people in rural areas: study protocol of a feasibility study

BACKGROUND: Age-related mobility limitations are associated with reduced activity and loss of participation, which can result in loneliness and depression. Physical activity programmes can help maintain the functional status and quality of life of older individuals, but they are rarely available and often difficult to reach, especially in rural areas. Digital-assisted programmes have the potential, independent of place and time, to activate and promote physical function and social participation in older people. Therefore, this study aims (1) to develop a complex intervention comprising digital elements to promote physical activity, quality of life and participation in older people with impending or existing functional limitations and (2) to test the feasibility, acceptability, and potential benefits of the developed intervention. METHODS: The development and piloting of the intervention follow the UK Medical Research Council framework for complex interventions. The intervention will be developed through participatory co-production, integrating the perspectives of all potentially relevant user groups, including older people, physiotherapists, general practitioners, and day care facilities in the participating regions. Co-production is guided by the principles of early stakeholder involvement, iterative refinement, usability-oriented development, and shared decision-making regarding intervention content and delivery. The developed intervention will be examined using a consecutive control intervention group design with 60 older people (aged ≥ 65 years) in rural areas of Saxony-Anhalt who have existing or imminent mobility restrictions and have a medical prescription for physiotherapy. The primary feasibility outcomes will be recruitment rate, completion rate, acceptability, and compliance with the study procedures and the intervention assessed by protocols, utilisation data, questionnaires, and interviews at 20-weeks follow-up. Quantitative and qualitative findings will be integrated during interpretation using a convergent mixed-methods approach. Secondary patient-related outcomes will be physical function, physical activity, self-care, quality of life, and participation measured at baseline and after 12 weeks. DISCUSSION: The study aims to evaluate the feasibility of a new intervention designed to promote physical activity and participation among older people living in rural areas. The findings will inform intervention refinement and the design of a future definitive randomised controlled trial. TRIAL REGISTRATION: DRKS, DRKS00031574. Registered on 5 May 2023, https://drks.de/search/de/trial/DRKS00031574 .