Knee Osteoarthritis
Conditions
Keywords
Risk assessment and Management Programme, Chronic Care Model
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.
Interventions
BEHAVIORALRisk assessment and Management Programme - Knee Osteoarthritis
(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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
All data collection will be performed by trained research assistants blinded to the allocation status of the patients, and statistician will analyse data without referring to allocation information.
Intervention model description
The study is a 52-week, two-arm, parallel, doubled-blinded randomized clinical trial, evaluating the clinical efficacy of RAMP-Knee OA (N=114) versus usual care (N=114) on self-reported knee pain and other secondary outcomes.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee pain | Baseline, week 16, week 32, week 52 | Knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographic data | Baseline | Demographic data such as height, weight, BMI, age, sex, knee pain duration, chronic comorbid conditions, chronic medications |
| Insomnia | Baseline, week 16, week 32, week 52 | Insomnia measured by 7 item Insomnia Severity Index |
| Loneliness | Baseline, week 16, week 32, week 52 | Loneliness measured by 6 item De Jong Gierveld Loneliness Scale |
| 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 |
| Health related Quality of Life | Baseline, week 16, week 32, week 52 | Health related Quality of life measured by Euroquol- 5D-5L |
| Level of physical activity | Baseline, week 16, week 32, week 52 | Level of physical activity measured by Chinese International Physical Activity Questionnaire (Short form) |
| Self-Management efficacy | Baseline, week 16, week 32, week 52 | Self-management efficacy measure by Pain-Self Efficacy questionnaire |
| Level of Anxiety | Baseline, week 16, week 32, week 52 | Anxiety measured by Generalized Anxiety Disorder -7 |
| Level of Depression | Baseline, week 16, week 32, week 52 | Depression measured by Patient Health Questionnaire -9 |
| Lower limb muscle mass | Baseline, week 16, week 32, week 52 | Lower limb muscle mass measured by bio-impedance analysis |
Countries
Hong Kong
Outcome results
None listed