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Enrolling by Invitation

NCT Number: NCT06596031

Health Coaching for Patients Waiting for Total Hip or Knee Replacements

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.

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Key information

Conditions

Arthritis Knee Arthritis of Hip

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Wellbeing Research Centre

Sheffield, S9 3TU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Global rating of change

    Time frame: 12 weeks

    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

  2. Perceived Satisfaction

    Time frame: 12 weeks

    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.

  3. Rate of retention

    Time frame: 12 weeks

    Bowens Framework - acceptability, percentage of participants progressing from baseline, to midpoint and post-intervention assessments

  4. Drop out rate

    Time frame: 12 weeks

    Bowens Framework - acceptability, percentage of people discontinuing in both groups

  5. Adverse events

    Time frame: 12 weeks

    Bowens Framework- practicality, measured by number, type and severity of adverse events

  6. Rate of service utilisation

    Time frame: 12 weeks

    Bowens Framework - implementation, measured by the number of attended sessions (health coaching) number of days during the week using the active wait website

  7. Rates of recruitment

    Time frame: 12 weeks

    Bowens Framework - demand, measured by n number of recruitment per week.

Secondary outcomes

  1. Demographics

    Time frame: 12 weeks

    height and weight aggregated to arrive at one reported value BMI, in units kg/m^2

  2. Arthritis Self-Efficacy Scale (ASES-8)

    Time frame: 12 weeks

    Self efficacy questionnaire. Contains 8 items, each measured on a scale from 1-10. Higher score indicates greater self-efficacy.

  3. International physical activity questionnaire-short form (IPAQ-SF)

    Time frame: 12 weeks

    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.

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

    Time frame: 12 week

    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.

  5. Visual Analogue Scale

    Time frame: 12 week

    VAS 10 point scale for self report of pain level. With 1 being no pain and 10 being maximal pain.

  6. Oxford knee/hip score

    Time frame: 12 week

    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.

  7. Knee flexion/extension strength

    Time frame: 12 week

    Biodex for isometric strength testing, peak torque will be calculated in N.m

  8. 4 x 10m walk test

    Time frame: 12 week

    The average time taken to complete a 10m lap (s)

  9. 12 steps test

    Time frame: 12 week

    Time taken to complete 1 flight of 12 steps (s)

  10. Time up and go

    Time frame: 12 week

    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)

  11. Sit to stand test

    Time frame: 12 week

    Number of full repetitions from sitting to standing in a 30s period

  12. Minutes in sedentary activities

    Time frame: 1 week baseline and 1 week at completion

    Wearable tracking using ActivPAL

Sponsors and collaborators

Lead sponsor

Sheffield Hallam University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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