Arthritis Knee, Arthritis of Hip
Conditions
Keywords
joint replacement surgery, digital resource, health coaching, telehealth, self management
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.
Interventions
BEHAVIORALHealth 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.
BEHAVIORALDigital 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.
Sponsors
Sheffield Hallam University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Pilot study of a single-blinded, randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Sit to stand test | 12 week | Number of full repetitions from sitting to standing in a 30s period |
| 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) |
| Minutes in sedentary activities | 1 week baseline and 1 week at completion | Wearable tracking using ActivPAL |
| 12 steps test | 12 week | Time taken to complete 1 flight of 12 steps (s) |
| 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. |
Countries
United Kingdom
Outcome results
None listed