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Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS).

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dc.contributor.author Hurley, Deirdre A.
dc.contributor.author Jeffares, Isabelle
dc.contributor.author Hall, Amanda M.
dc.contributor.author Keogh, Alison
dc.contributor.author Toomey, Elaine C.
dc.contributor.author McArdle, Danielle
dc.contributor.author McDonough, Suzanne M.
dc.contributor.author Guerin, Suzanne
dc.contributor.author Segurado, Ricardo
dc.contributor.author Matthews, James
dc.date.accessioned 2020-11-13T15:35:37Z
dc.date.available 2020-11-13T15:35:37Z
dc.date.issued 2020
dc.identifier.issn 1745-6215
dc.identifier.uri http://hdl.handle.net/10344/9457
dc.description peer-reviewed en_US
dc.description.abstract 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. 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, 6â weeks (behaviour change only), 2â months and 6â 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. Fourteen clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (intervention: mean (SD)â =â 4.92 (1.31), range 2-7; UP: mean (SD)â =â 5.08 (2.43), range 1-9). One hundred twenty participants (83.3% of nâ =â 144 expected) were recruited (intervention nâ =â 59; UP nâ =â 61), with follow-up data obtained from 80.8% (nâ =â 97) at 6â weeks, 84.2% (nâ =â 101) at 2â months and 71.7% (nâ =â 86) at 6â months. Most participants received treatment as allocated (intervention nâ =â 49; UP nâ =â 54). The qualitative interviews (12 participants; 10 physiotherapists (PTs) found the intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6â months with small between-group effects. While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial. ISRCTN ISRCTN49875385 . Registered on 26 March 2014. en_US
dc.language.iso eng en_US
dc.publisher BMC en_US
dc.relation.ispartofseries Trials;21: 807
dc.subject complex group intervention en_US
dc.subject feasibility cluster randomised controlled trial en_US
dc.subject self-management en_US
dc.subject behaviour change intervention en_US
dc.subject qualitative methods en_US
dc.title Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS). en_US
dc.type info:eu-repo/semantics/article en_US
dc.type.supercollection all_ul_research en_US
dc.type.supercollection ul_published_reviewed en_US
dc.date.updated 2020-11-13T15:29:15Z
dc.description.version PUBLISHED
dc.identifier.doi 10.1186/s13063-020-04671-x
dc.contributor.sponsor HRB en_US
dc.relation.projectid HRA_HSR/2012/24 en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US
dc.internal.rssid 2974693
dc.internal.copyrightchecked Yes
dc.identifier.journaltitle Trials
dc.description.status peer-reviewed


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