Health Coaching for Patients Waiting for Total Hip or Knee Replacements
- Conditions
- Arthritis KneeArthritis of Hip
- Interventions
- Behavioral: Health coachingBehavioral: Digital toolkit
- Registration Number
- NCT06596031
- Lead Sponsor
- Sheffield Hallam University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Health coaching 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. Digital toolkit 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/
- Primary Outcome Measures
Name Time Method Global rating of change 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
Perceived Satisfaction 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.
Rate of retention 12 weeks Bowens Framework - acceptability, percentage of participants progressing from baseline, to midpoint and post-intervention assessments
Drop out rate 12 weeks Bowens Framework - acceptability, percentage of people discontinuing in both groups
Adverse events 12 weeks Bowens Framework- practicality, measured by number, type and severity of adverse events
Rate of service utilisation 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
Rates of recruitment 12 weeks Bowens Framework - demand, measured by n number of recruitment per week.
- Secondary Outcome Measures
Name Time Method Demographics 12 weeks height and weight aggregated to arrive at one reported value BMI, in units kg/m\^2
Arthritis Self-Efficacy Scale (ASES-8) 12 weeks Self efficacy questionnaire. Contains 8 items, each measured on a scale from 1-10. Higher score indicates greater self-efficacy.
International physical activity questionnaire-short form (IPAQ-SF) 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.
EuroQoL Group's 5-dimension (EQ-5D-5L) 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.
Visual Analogue Scale 12 week VAS 10 point scale for self report of pain level. With 1 being no pain and 10 being maximal pain.
Oxford knee/hip score 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.
Knee flexion/extension strength 12 week Biodex for isometric strength testing, peak torque will be calculated in N.m
4 x 10m walk test 12 week The average time taken to complete a 10m lap (s)
12 steps test 12 week Time taken to complete 1 flight of 12 steps (s)
Time up and go 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)
Sit to stand test 12 week Number of full repetitions from sitting to standing in a 30s period
Minutes in sedentary activities 1 week baseline and 1 week at completion Wearable tracking using ActivPAL