Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual
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RESEARCH
Open Access
Feasibility cluster randomised controlled trial evaluating a theory-driven groupbased complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS) Deirdre A. Hurley1* , Isabelle Jeffares2, Amanda M. Hall3, Alison Keogh1, Elaine Toomey4, Danielle McArdle1, Suzanne M. McDonough5, Suzanne Guerin6, Ricardo Segurado1 and James Matthews1
Abstract Background: The self-management of osteoarthritis (OA) and low back pain (LBP) through activity and skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. Methods: This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland, between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants’ cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. (Continued on next page)
* Correspondence: [email protected] 1 School of Public Health, Physiotherapy and Sports Science, University College Dublin, Room A302, Health Sciences Centre, Belfield, Dublin 4, Ireland Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Common
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