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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
228
(i) Arthritis education: Topics will cover the 21 key messages identified in International Consensus List of Essential Statements for Osteoarthritis "What Do People With Knee or Hip Osteoarthritis Need to Know" (ii) Structured land-based exercise: We have selected strengthening, flexibility training (stretching), and aerobic exercise as our key components because they are most applicable in primary care settings. (iii) Weight Management: Weight management will be offered for participants with a BMI ≥ 23 kg/m2. (iv) Counselling support for psychosocial health: counselling support will be provided for those with mild to moderate anxiety and depression, insomnia and loneliness identified in the risk assessment. (v) Dietary advice: Online dietary education for musculoskeletal health (with reference to local context) will be provided. The dietitian will also provide support regarding specific dietary advice on weight management.
Lek Yuen GOPC
Hong Kong, Hong Kong
Knee pain
Knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, week 16, week 32, week 52
Physical Function
Physical function measured by WOMAC function subscale
Time frame: Baseline, week 16, week 32, week 52
Physical function
Physical function measured by 30-second chair and stand performance test
Time frame: Baseline, week 16, week 32, week 52
Lower limb muscle mass
Lower limb muscle mass measured by bio-impedance analysis
Time frame: Baseline, week 16, week 32, week 52
Level of physical activity
Level of physical activity measured by Chinese International Physical Activity Questionnaire (Short form)
Time frame: Baseline, week 16, week 32, week 52
Self-Management efficacy
Self-management efficacy measure by Pain-Self Efficacy questionnaire
Time frame: Baseline, week 16, week 32, week 52
Level of Anxiety
Anxiety measured by Generalized Anxiety Disorder -7
Time frame: Baseline, week 16, week 32, week 52
Level of Depression
Depression measured by Patient Health Questionnaire -9
Time frame: Baseline, week 16, week 32, week 52
Insomnia
Insomnia measured by 7 item Insomnia Severity Index
Time frame: Baseline, week 16, week 32, week 52
Loneliness
Loneliness measured by 6 item De Jong Gierveld Loneliness Scale
Time frame: Baseline, week 16, week 32, week 52
Health related Quality of Life
Health related Quality of life measured by Euroquol- 5D-5L
Time frame: Baseline, week 16, week 32, week 52
Demographic data
Demographic data such as height, weight, BMI, age, sex, knee pain duration, chronic comorbid conditions, chronic medications
Time frame: Baseline
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