Citation

Forster A, Airlie J, Birch K, Cicero R, Cundill B, Ellwood A, Godfrey M, Graham L, Green J, Hulme C, Lawton R, McLellan V, McMaster N, Farrin A. Trials 2017; 18(1): e182.

Affiliation

Clinical Trials Research Unit, University of Leeds, Leeds, UK.

Copyright

(Copyright © 2017, Holtzbrinck Springer Nature Publishing Group - BMC)

DOI

10.1186/s13063-017-1921-8

PMID

28424088

PMCID

PMC5395795

Abstract

BACKGROUND: As life expectancy increases and the number of older people, particularly those aged 85 years and over, expands there is an increase in demand for long-term care. A large proportion of people in a care home setting spend most of their time sedentary, and this is one of the leading preventable causes of death. Encouraging residents to engage in more physical activity could deliver benefits in terms of physical and psychological health, and quality of life. This study is the final stage of a programme of research to develop and preliminarily test an evidence-based intervention designed to enhance opportunities for movement amongst care home residents, thereby increasing levels of physical activity.

METHODS/DESIGN: This is a cluster randomised feasibility trial, aiming to recruit at least 8-12 residents at each of 12 residential care homes across Yorkshire, UK. Care homes will be randomly allocated on a 1:1 basis to receive either the intervention alongside usual care, or to continue to provide usual care alone. Assessment will be undertaken with participating residents at baseline (prior to care home randomisation) and at 3, 6, and 9 months post-randomisation. Data relating to changes in physical activity, physical function, level of cognitive impairment, mood, perceived health and wellbeing, and quality of life will be collected. Data at the level of the home will also be collected and will include staff experience of care, and changes in the numbers and types of adverse events residents experience (for example, hospital admissions, falls). Details of National Health Service (NHS) usage will be collected to inform the economic analysis. An embedded process evaluation will obtain information to test out the theory of change underpinning the intervention and its acceptability to staff and residents.

DISCUSSION: This feasibility trial with embedded process evaluation and collection of health economic data will allow us to undertake detailed feasibility work to inform a future large-scale trial. It will provide valuable information to inform research procedures in this important but challenging area. TRIAL REGISTRATION: ISRCTN registry, ISRCTN16076575. Registered on 25 June 2015.

Language: en

Keywords

Care homes; Cluster randomised controlled trial; Elderly; Feasibility; Movement; Physical activity; Sedentary