1. A brief physiotherapist-led behaviour-change intervention to facilitate walking in older people with peripheral arterial disease: development of a protocol for a randomized controlled trial.
- Author
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Holmes, M. N. Galea, Weinman, J. A., Peacock, J., Eddy, S., Modarai, B., Patel, S., Fisher, G., Sackley, C., and Bearne, L. M.
- Subjects
BEHAVIOR modification ,CONFERENCES & conventions ,PERIPHERAL vascular diseases ,PHYSICAL therapy - Abstract
Background: Walking is a recommended but underused treatment for intermittent claudication (IC) caused by peripheral arterial disease. Following feasibility evaluation, the trial protocol to investigate the efficacy of a novel physiotherapist-led intervention targeting walking in people with IC (MOtivating Structured walking Activity for Intermittent Claudication (MOSAIC)) vs. usual care was developed. Methods: A two-arm feasibility trial was conducted to evaluate participant recruitment and retention, suitability of outcomes (6-Minute Walk Distance (6MWD), pedometer-assessed walking) and acceptability of MOSAIC. MOSAIC includes two 60-minute face-to-face sessions and two 20-minute telephone sessions delivered by a physiotherapist trained in motivational interviewing and behaviour-change techniques. Results: The recruitment rate was 26% of eligible patients. Study retention (92%) and treatment adherence (71%) were high. 6MWD (no missing data) was a superior outcome to pedometer walking activity (up to 36% missing data). Participants reported MOSAIC was acceptable. Discussion: Informed by the successful feasibility trial, a multicentre, two-arm, superiority trial with a nested qualitative study and process evaluation was developed. A total of 192 people with IC will be randomly allocated (1:1, stratified by site) to MOSAIC or usual care. The primary outcome is walking (6MWD) at three months. Secondary outcomes include walking, daily activities, and quality of life (three and six months). Analyses according to intention-to-treat will be conducted using multiple regression. Qualitative interviews analysed thematically will explore the acceptability of MOSAIC in a subsample of participants and physiotherapists. Conclusion: If efficacious, MOSAIC will enable people with IC to improve their mobility, daily activities, and quality of life. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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