Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care- a One-year Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Knee pain
研究概览
简要总结
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):
- RAMP Knee-OA group
- Usual care group
Outcomes will be measured at baseline, week 16, week 32, and week 52.
详细描述
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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Knee pain
时间窗: Baseline, week 16, week 32, week 52
Knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
次要结局
- Physical Function(Baseline, week 16, week 32, week 52)
- Physical function(Baseline, week 16, week 32, week 52)
- Loneliness(Baseline, week 16, week 32, week 52)
- Self-Management efficacy(Baseline, week 16, week 32, week 52)
- Level of Depression(Baseline, week 16, week 32, week 52)
- Demographic data(Baseline)
- Lower limb muscle mass(Baseline, week 16, week 32, week 52)
- Level of physical activity(Baseline, week 16, week 32, week 52)
- Level of Anxiety(Baseline, week 16, week 32, week 52)
- Insomnia(Baseline, week 16, week 32, week 52)
- Health related Quality of Life(Baseline, week 16, week 32, week 52)
研究者
Regina Wing Shan Sit
Professor Regina Wing Shan Sit
Chinese University of Hong Kong