Clinical trial NCT06596031: Health Coaching for Patients Waiting for Total Hip or Knee Replacements
Official 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Arthritis Knee
Arthritis of Hip
Keywords: joint replacement surgery
digital resource
health coaching
telehealth
self management
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study of a single-blinded, randomised controlled trial
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Global rating of change
timeFrame: 12 weeks
measure: Perceived Satisfaction
timeFrame: 12 weeks
measure: Rate of retention
timeFrame: 12 weeks
measure: Drop out rate
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
measure: Rate of service utilisation
timeFrame: 12 weeks
measure: Rates of recruitment
timeFrame: 12 weeks
Secondary outcomes:
measure: Demographics
timeFrame: 12 weeks
measure: Arthritis Self-Efficacy Scale (ASES-8)
timeFrame: 12 weeks
measure: International physical activity questionnaire-short form (IPAQ-SF)
timeFrame: 12 weeks
measure: EuroQoL Group's 5-dimension (EQ-5D-5L)
timeFrame: 12 week
measure: Visual Analogue Scale
timeFrame: 12 week
measure: Oxford knee/hip score
timeFrame: 12 week
measure: Knee flexion/extension strength
timeFrame: 12 week
measure: 4 x 10m walk test
timeFrame: 12 week
measure: 12 steps test
timeFrame: 12 week
measure: Time up and go
timeFrame: 12 week
measure: Sit to stand test
timeFrame: 12 week
measure: Minutes in sedentary activities
timeFrame: 1 week baseline and 1 week at completion
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Advanced Wellbeing Research Centre
Study officials:
References:
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