A cluster randomised feasibility pilot trial evaluating involving community-dwelling older adults in activities in relation to meals in a rehabilitation program; recruitment, data collection and protocol

Abstract Background Community-dwelling older adults receiving support at home such as meals-on-wheels may lose the ability to preserve social, cognitive, and functional abilities, when becoming accustomed to and dependent of community aged care. When still able to cook older adults often hold some control over the foods that are prepared and which they eat, and which helps to foster identity. The purpose of this study is to assess feasibility of outcome measurements and sample size when conducting a pilot cluster randomized trial to evaluate community-dwelling older adults being involved in activities in relation to meals in a rehabilitation program. Methods This cluster randomized controlled study will consist of two clusters of a total of 5 community aged care areas; the intervention cluster, which hold 3 community aged care areas and the control cluster which hold 2 areas. The 130 community-dwelling older adults, receiving meals-on-wheels, will randomly be allocated to either the intervention cluster consisting of 8 weeks of participation in a rehabilitation program led by a Case Manager or the control cluster receiving usual community aged care. The primary outcome will be assessment of data collection (ratio between completed- and non-completed data) and assessment of sample size. The secondary clinical outcomes will be health-related quality of life (EQ-5D-3 L), muscle strength (chair stand), nutritional status (weight/BMI), loneliness (UCLA scale), mental well-being (Warwich-Edinburgh scale), self-efficacy (General Self-Efficacy scale), satisfaction with food-related life (SWFL scale) and refrigerator content. Discussion This study evaluates community-dwelling older adults receiving support at home, using involvement in activities related to meals with a rehabilitation approach, and this is a new area of research and will therefore be contributing in developing and refining consistent practices of rehabilitation programs. Trial registration ClinicalTrials.gov (registration no: NCT03289598). The protocol has been sent to the Danish Ethical Board which has concluded that approval is not needed and that the study can be carried on as described. Approval by The Danish Data Protection Agency has been giving through general approval for use of data in The City of Odense and will follow rules for obtaining the data accordingly.