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Health Coaching for Patients Waiting for Total Hip or Knee Replacements

Not Applicable
Conditions
Arthritis Knee
Arthritis of Hip
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
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
36
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Global rating of change12 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 Satisfaction12 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 retention12 weeks

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

Adverse events12 weeks

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

Rate of service utilisation12 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 recruitment12 weeks

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

Drop out rate12 weeks

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

Secondary Outcome Measures
NameTimeMethod
Demographics12 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 Scale12 week

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

Oxford knee/hip score12 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 strength12 week

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

12 steps test12 week

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

Time up and go12 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 test12 week

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

Minutes in sedentary activities1 week baseline and 1 week at completion

Wearable tracking using ActivPAL

4 x 10m walk test12 week

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

Trial Locations

Locations (1)

Advanced Wellbeing Research Centre

🇬🇧

Sheffield, United Kingdom

Advanced Wellbeing Research Centre
🇬🇧Sheffield, United Kingdom

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