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Home-based pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): a feasibility randomised controlled trial

das Nair, Roshan; Mhizha-Murira, Jacqueline R.; Anderson, Pippa; Carpenter, Hannah; Clarke, Simon; Groves, Sam; Leighton, Paul; Scammell, Brigitte E.; Topcu, Gogem; Walsh, David A.; Lincoln, Nadina B.

Authors

ROSHAN NAIR Roshan.dasnair@nottingham.ac.uk
Professor of Clinical Psychology and Neuropsychology

Jacqueline R. Mhizha-Murira

Pippa Anderson

Hannah Carpenter

Simon Clarke

Sam Groves

PAUL LEIGHTON PAUL.LEIGHTON@NOTTINGHAM.AC.UK
Associate Professor of Applied Health Services Research

Brigitte E. Scammell

GOGEM TOPCU GOGEM.TOPCU@NOTTINGHAM.AC.UK
Programme Manager (Neuroms)

DAVID WALSH david.walsh@nottingham.ac.uk
Professor of Rheumatology

Nadina B. Lincoln



Abstract

Objective: To determine the feasibility of conducting a trial of a pre-surgical psychological intervention on pain, function, and mood in people with knee osteoarthritis listed for total knee arthroplasty.
Design: Multi-centre, mixed-methods feasibility randomized controlled trial of intervention plus usual care versus usual care.
Setting: Participants’ homes or hospital.
Participants: Patients with knee osteoarthritis listed for total knee arthroplasty and score >7 on either subscales of Hospital Anxiety and Depression Scale.
Intervention: Up-to 10 sessions of psychological intervention (based on cognitive behavioural therapy).
Main measures: Feasibility outcomes (recruitment and retention rates, acceptability of trial procedures and intervention, completion of outcome measures), and standardized questionnaires assessing pain, function, and mood at baseline, and four and six months post-randomisation.
Results: Of 222 people screened, 81 did not meet inclusion criteria, 64 did not wish to participate, 26 were excluded for other reasons, and 51 were randomized. A total of 30 completed 4-months outcomes and 25 completed 6-month outcomes. Modal number of intervention sessions completed was three (range 2–8). At six-month follow-up, mood, pain, and physical function scores were consistent with clinically important benefits from intervention, with effect sizes ranging from small (d = 0.005) to moderate (d = 0.74), and significant differences in physical function between intervention and usual care groups (d = 1.16). Feedback interviews suggested that participants understood the rationale for the study, found the information provided adequate, the measures comprehensive, and the intervention acceptable.
Conclusion: A definitive trial is feasible, with a total sample size of 444 people. Pain is a suitable primary outcome, but best assessed 6 and 12 months post-surgery.

Citation

das Nair, R., Mhizha-Murira, J. R., Anderson, P., Carpenter, H., Clarke, S., Groves, S., …Lincoln, N. B. (2018). Home-based pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): a feasibility randomised controlled trial. Clinical Rehabilitation, 32(6), 777-789. https://doi.org/10.1177/0269215518755426

Journal Article Type Article
Acceptance Date Jan 3, 2018
Online Publication Date Feb 9, 2018
Publication Date 2018-06
Deposit Date Jan 22, 2018
Publicly Available Date Mar 28, 2024
Journal Clinical Rehabilitation
Print ISSN 0269-2155
Electronic ISSN 1477-0873
Publisher SAGE Publications
Peer Reviewed Peer Reviewed
Volume 32
Issue 6
Pages 777-789
DOI https://doi.org/10.1177/0269215518755426
Keywords Psychological intervention, total knee arthroplasty, knee osteoarthritis, randomized controlled trial, feasibility
Public URL https://nottingham-repository.worktribe.com/output/911129
Publisher URL http://journals.sagepub.com/doi/10.1177/0269215518755426