Health Coaching for Patients Waiting for Total Hip or Knee Replacements

Official title

Health Coaching in Addition to a Digital Resource to Promote Self-management for Patients Waiting for Total Hip or Knee Replacements: A Randomised Feasibility Trial

Overview

This pilot study aims to evaluate the feasibility of collecting objective data on physical performance to measure the impact of health coaching in addition to a digital resource (Active Wait) and enable sample size calculation for a larger scale RCT.

Interventions

• Behavioral Health coaching
  The core belief in coaching is that people are resourceful and that the participant knows what is best for themselves. If the participants are assigned to the health coaching group, they will have access to a health coach with a physiotherapist background. Instead of offering physiotherapy advice, however, the health coaching will work with the participant to come up with ideas that work the best for them to manage their health and wellness to prepare for surgery, including addressing some diffi
• Behavioral Digital toolkit
  This intervention provides, via a website, self-management support of preoperative rehabilitation for hip or knee replacement based on NICE guidelines Joint replacement (primary): hip and knee. This includes guidance for patients to undertake a strengthening programme that will aid recovery, lifestyle behaviours including weight management, diet and smoking cessation, and maximising functional independence and quality of life before surgery.

Primary outcome measures

• Global rating of change [Time frame: 12 weeks]
• Perceived Satisfaction [Time frame: 12 weeks]
• Rate of retention [Time frame: 12 weeks]
• Drop out rate [Time frame: 12 weeks]
• Adverse events [Time frame: 12 weeks]
• Rate of service utilisation [Time frame: 12 weeks]
• Rates of recruitment [Time frame: 12 weeks]

Secondary outcome measures (12)

• Demographics [Time frame: 12 weeks]
• Arthritis Self-Efficacy Scale (ASES-8) [Time frame: 12 weeks]
• International physical activity questionnaire-short form (IPAQ-SF) [Time frame: 12 weeks]
• EuroQoL Group's 5-dimension (EQ-5D-5L) [Time frame: 12 week]
• Visual Analogue Scale [Time frame: 12 week]
• Oxford knee/hip score [Time frame: 12 week]
• Knee flexion/extension strength [Time frame: 12 week]
• 4 x 10m walk test [Time frame: 12 week]
• 12 steps test [Time frame: 12 week]
• Time up and go [Time frame: 12 week]
• Sit to stand test [Time frame: 12 week]
• Minutes in sedentary activities [Time frame: 1 week baseline and 1 week at completion]

Eligibility criteria

Inclusion criteria

• patients scheduled on the waitlist for a total joint replacement surgery for hip/knee, ie clinically and radiographically diagnosed, symptomatic knee/hip osteoarthritis deemed suitable for surgical intervention;
• have access to the internet and the ability to navigate web-based programs;
• able and willing to travel to Advanced Wellbeing Research Centre for baseline and follow-up assessments;
• able to comprehend the requirements and purpose of the study and give informed consent

Exclusion criteria

• other musculoskeletal lower limb or back conditions requiring assessment or treatment by a health professional in the last 6 months;
• neurological impairment or condition affecting lower limb function; conditions listed as both absolute and relative contraindications for physical activities by the American College of Sports Medicine (ACSM), such as unstable angina, uncontrolled diabetes;
• systemic inflammatory disease (e.g. rheumatoid arthritis);
• previous total joint replacement surgery (hip or knee)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

United Kingdom · 1 center

• Advanced Wellbeing Research Centre — Sheffield

Publications

• Abbott JH, Schmitt J. Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale. J Orthop Sports Phys Ther. 2014 Aug;44(8):560-4. doi: 10.2519/jospt.2014.5248. Epub 2014 May 14. PMID 24828475
• Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002. PMID 19362699
• Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical PMID 33239350
• Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13. PMID 23680877
• Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x. PMID 15189396
• Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115. PMID 22018588
• Lienhard K, Lauermann SP, Schneider D, Item-Glatthorn JF, Casartelli NC, Maffiuletti NA. Validity and reliability of isometric, isokinetic and isoinertial modalities for the assessment of quadriceps muscle strength in patients with total knee arthroplasty. J Electromyogr Kinesiol. 2013 Dec;23(6):1283-8. doi: 10.1016/j.jelekin.2013.09.004. Epub 2013 Sep 23. PMID 24113423
• Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107. PMID 2912463

Identifiers

NCT: NCT06596031 · ER68359613

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗