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

Abstract

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 follows the UK Medical Research Council framework for complex interventions. The intervention will be developed through participatory, co-creative processes that integrate the perspectives of all potentially relevant user groups, including older people, physiotherapists, general practitioners, and day care facilities in the participating regions. The developed intervention will be piloted 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, data analysis and interviews at 20-weeks follow-up. This will include evaluating adherence, utilization data, as well as identifying barriers and facilitators, using a mixed-methods design. The 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 pilot study will serve as a basis for an individual randomized trial to test the intervention's effectiveness. The results will inform the adaptation of the intervention to a prescribable healthcare approach. Trial registration DRKS, DRKS00031574. Registered on 5 May 2023, https//drks.de/search/de/trial/DRKS00031574