Health Coaching for Patients Waiting for Total Hip or Knee Replacements

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Arthritis Knee; Arthritis of Hip
• Intervention / Treatment: Behavioral: Health coaching; Behavioral: Digital toolkit

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom, S9 3TU
    • Advanced Wellbeing Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health coaching; Participants randomized to the intervention group will receive access to the Active Wait program, which includes remote, self-paced (asynchronous) education, exercise, and nutritional advice delivered via a web-based platform. The participants in the intervention group will have access to the program, in conjunction with health coaching. Patients undertaking health coaching will be assigned a personal health coach who will provide support to increase their ability to self-manage through self- regulation principles of behaviour change. Health coaching sessions will be delivered remotely (via telephone or video conferencing) a maximum of 8-times during a 12-week intervention period. Sessions are limited to 1 hour, offering education, self-management strategies, barrier and facilitator identification, support and encouragement, goal setting, action planning and self-monitoring with the intention to facilitate positive and sustainable lifestyle and behaviour changes.	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 difficulties the participant are facing when using the online resource.
Active Comparator: Digital toolkit; Patients in the active-comparator group will be given a link to the same Digital Toolkit. The digital toolkit is a 12-week non-contact programme titled Active Wait, which offers education, self-management techniques and an unsupervised strength programme. The website Active Wait can be accessed via the link: https://protect-au.mimecast.com/s/8_5gCP7yRZiWn3q3FzwqnS?domain=sheffieldachesandpains.com/	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global rating of change	Bowens Framework - acceptability (Perceived benefits) 7-point likert scale global rating of change (GROC) with -3 being worse, 0 being no change and 3 being better	12 weeks
Perceived Satisfaction	Bowens Framework - acceptability (Perceived satisfaction). How satisfied were you with the overall information, level of support, and ease of use of the program? Measured on a numeric rating scale, where 0 means not satisfied, 10 means significant satisfaction.	12 weeks
Rate of retention	Bowens Framework - acceptability, percentage of participants progressing from baseline, to midpoint and post-intervention assessments	12 weeks
Drop out rate	Bowens Framework - acceptability, percentage of people discontinuing in both groups	12 weeks
Adverse events	Bowens Framework- practicality, measured by number, type and severity of adverse events	12 weeks
Rate of service utilisation	Bowens Framework - implementation, measured by the number of attended sessions (health coaching) number of days during the week using the active wait website	12 weeks
Rates of recruitment	Bowens Framework - demand, measured by n number of recruitment per week.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	height and weight aggregated to arrive at one reported value BMI, in units kg/m^2	12 weeks
Arthritis Self-Efficacy Scale (ASES-8)	Self efficacy questionnaire. Contains 8 items, each measured on a scale from 1-10. Higher score indicates greater self-efficacy.	12 weeks
International physical activity questionnaire-short form (IPAQ-SF)	Physical activity level is measured in three categories, walking, moderate-intensity activities, vigorous-intensity activities, in addition to sitting. Their score is then expressed as MET-min per week.	12 weeks
EuroQoL Group's 5-dimension (EQ-5D-5L)	Health related quality of life questionnaire. Each dimension of the EQ-5D has 5 levels from 1-5. 1 indicates full health state, 5 indicates worse the problem. The last question, EQ-5D health scale is a scale between 0-100, where 0 indicates worst health, 100 indicates best health.	12 week
Visual Analogue Scale	VAS 10 point scale for self report of pain level. With 1 being no pain and 10 being maximal pain.	12 week
Oxford knee/hip score	Joint specific function questionnaire. The questionnaire contains 6 questions. Each question ranges from 0 to 4, with 4 being the best outcome. The highest score is 48.	12 week
Knee flexion/extension strength	Biodex for isometric strength testing, peak torque will be calculated in N.m	12 week
4 x 10m walk test	The average time taken to complete a 10m lap (s)	12 week
12 steps test	Time taken to complete 1 flight of 12 steps (s)	12 week
Time up and go	Amount of time taken to complete a lap from sitting to standing, walking for 3 m, turn around a marker and return to sitting position (s)	12 week
Sit to stand test	Number of full repetitions from sitting to standing in a 30s period	12 week
Minutes in sedentary activities	Wearable tracking using ActivPAL	1 week baseline and 1 week at completion

Collaborators and Investigators

• Sponsor: Sheffield Hallam University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.
• 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.
• 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 activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
• 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.
• Lyden K, Keadle SK, Staudenmayer J, Freedson PS. The activPALTM Accurately Classifies Activity Intensity Categories in Healthy Adults. Med Sci Sports Exerc. 2017 May;49(5):1022-1028. doi: 10.1249/MSS.0000000000001177.
• 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.
• Norman R, Cronin P, Viney R. A pilot discrete choice experiment to explore preferences for EQ-5D-5L health states. Appl Health Econ Health Policy. 2013 Jun;11(3):287-98. doi: 10.1007/s40258-013-0035-z.
• Sarabon N, Ceh T, Kozinc Z, Smajla D. Adapted protocol of rate of force development and relaxation scaling factor for neuromuscular assessment in patients with knee osteoarthritis. Knee. 2020 Dec;27(6):1697-1707. doi: 10.1016/j.knee.2020.09.023. Epub 2020 Nov 13.
• Wallis JA, Webster KE, Levinger P, Taylor NF. What proportion of people with hip and knee osteoarthritis meet physical activity guidelines? A systematic review and meta-analysis. Osteoarthritis Cartilage. 2013 Nov;21(11):1648-59. doi: 10.1016/j.joca.2013.08.003. Epub 2013 Aug 12.
• Wilcox S, Schoffman DE, Dowda M, Sharpe PA. Psychometric properties of the 8-item english arthritis self-efficacy scale in a diverse sample. Arthritis. 2014;2014:385256. doi: 10.1155/2014/385256. Epub 2014 Aug 21.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: self management; telehealth; health coaching; joint replacement surgery; digital resource
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Arthritis
• Other Study ID Numbers: ER68359613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study assessing the feasibility of conducting a larger scale randomised control trial. Limited efficacy is the secondary outcome only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No