Health Coaching for Patients Waiting for Total Hip or Knee Replacements

NCT06596031 | Enrolling By Invitation

• 1 other identifier: ER68359613
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthritis Knee; Arthritis of Hip

Keywords

joint replacement surgery; digital resource; health coaching; telehealth; self management

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (12)

• Demographics

  12 weeks

• Arthritis Self-Efficacy Scale (ASES-8)

  12 weeks

• International physical activity questionnaire-short form (IPAQ-SF)

  12 weeks

• EuroQoL Group's 5-dimension (EQ-5D-5L)

  12 week

• Visual Analogue Scale

  12 week

Study Arms (2)

Health coaching

EXPERIMENTAL

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

Digital toolkit

ACTIVE COMPARATOR

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

Interventions

Health coaching BEHAVIORAL

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.

Health coaching

Digital toolkit BEHAVIORAL

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.

Digital toolkit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sheffield Hallam University: lead

Study Sites (1)

Advanced Wellbeing Research Centre

Sheffield, S9 3TU, United Kingdom

Location

Related Publications (14)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study of a single-blinded, randomised controlled trial

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: February 27, 2025
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)