Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care
- Conditions
- Knee Osteoarthritis
- Interventions
- Behavioral: Risk assessment and Management Programme - Knee Osteoarthritis
- Registration Number
- NCT06283147
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks.
Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):
1. RAMP Knee-OA group
2. Usual care group
Outcomes will be measured at baseline, week 16, week 32, and week 52.
- Detailed Description
The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks. RAMP-knee OA is designed based on the validated framework of CCM, which identifies six important components including self-management support, clinical information systems, delivery system redesign, decision support, health care organization, and community resources.
The main questions the study aims to answer are:
In comparison with people undergoing usual care, whether:
* Participants in the RAMP-Knee OA group will report greater improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale
* Participants in the RAMP-Knee OA group will report greater improvement in physical function, self-management efficacy, lower limb muscle mass, psychosocial health, and quality of life
Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):
1. RAMP Knee-OA group: Participants will be referred to the RAMP-Knee OA clinic operated by a Registered Nurse, which will be a face-to-face consultation scheduled every 4 months following patients' usual clinic appointments. A total of 4 sessions will be provided for each enrolled participant over one year. The content of the Programme centers around arthritis education, structure-land base exercise, and weight management, with the additional component of counseling support and dietary advice on musculoskeletal health.
2. Usual care group: Participants allocated to the usual care group will continue with their standard usual care (follow-up appointment at General Out Patient Clinic (GOPC) is typically every 4 months). The management approach for knee OA and other chronic diseases will be solely at the discretion of the attending physicians.
Outcomes will be measured at baseline, week 16, week 32, and week 52. Demographic data and knee pain duration will be collected at baseline assessment. Outcomes to measure include the severity of knee pain, physical function, level of physical activity, self-efficacy, level of anxiety and depression, insomnia, loneliness, health-related quality of life, and lower limb muscle mass. The use of co-intervention, analgesics, and other over-the-counter drugs will be recorded.
The baseline characteristics of the two groups will be compared using the independent samples t-test or the Mann-Whitney test for continuous variables and chi-square test for categorical variables.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 228
- Diagnosis of Knee OA based on clinical criteria of the American Rheumatology College
- Moderate to severe Knee pain for 3 months or longer (average score of 4 or greater on a 0-10 pain scale in the past 3 months)
- Participants with potential serious knee pathology (e.g. inflammatory arthritis, acute trauma, malignancy)
- Previous Knee replacement
- Scheduled knee joint replacement surgery within 1 year
- Participants who are unable to reliably participate (e.g. those who do not speak Chinese or unable to attend study intervention)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RAMP Knee OA Risk assessment and Management Programme - Knee Osteoarthritis Patients allocated to the intervention group will continue their "usual care" at the GOPCs, plus enrolment into the RAMP-Knee OA program.
- Primary Outcome Measures
Name Time Method Knee pain Baseline, week 16, week 32, week 52 Knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
- Secondary Outcome Measures
Name Time Method Physical Function Baseline, week 16, week 32, week 52 Physical function measured by WOMAC function subscale
Physical function Baseline, week 16, week 32, week 52 Physical function measured by 30-second chair and stand performance test
Loneliness Baseline, week 16, week 32, week 52 Loneliness measured by 6 item De Jong Gierveld Loneliness Scale
Self-Management efficacy Baseline, week 16, week 32, week 52 Self-management efficacy measure by Pain-Self Efficacy questionnaire
Level of Depression Baseline, week 16, week 32, week 52 Depression measured by Patient Health Questionnaire -9
Demographic data Baseline Demographic data such as height, weight, BMI, age, sex, knee pain duration, chronic comorbid conditions, chronic medications
Lower limb muscle mass Baseline, week 16, week 32, week 52 Lower limb muscle mass measured by bio-impedance analysis
Level of physical activity Baseline, week 16, week 32, week 52 Level of physical activity measured by Chinese International Physical Activity Questionnaire (Short form)
Level of Anxiety Baseline, week 16, week 32, week 52 Anxiety measured by Generalized Anxiety Disorder -7
Insomnia Baseline, week 16, week 32, week 52 Insomnia measured by 7 item Insomnia Severity Index
Health related Quality of Life Baseline, week 16, week 32, week 52 Health related Quality of life measured by Euroquol- 5D-5L
Trial Locations
- Locations (1)
Lek Yuen GOPC
ðŸ‡ðŸ‡°Hong Kong, Hong Kong