Optimizing Osteoarthritis Care Through Clinical and Community Partnership
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
研究概览
简要总结
The purpose of this study is to test the OA Clinic-Community CARE Model (OA CARE) which will address all recommended components of knee/hip (osteoarthritis) OA care, include interventions for both patients and primary care providers (PCPs), and utilize a tailored approach that efficiently matches treatments with patients' needs.
The patient component of OA CARE will include evidence-based weight management and exercise programs for all participants (delivered through the YMCA), as well as tailored referrals to physical therapy, additional weight management or nutrition services, sleep-related services and psychological services.
The PCP component of OA CARE will include a video-based summary of current OA treatment guidelines (with emphasis on practical application), collaboration on patients' referrals to specific services described above, and progress reports on enrolled patients.
详细描述
This study will be a randomized pilot trial of OA CARE among n=60 patients with knee and/or hip osteoarthritis (OA) and overweight/obesity who are not currently meeting physical activity recommendations. Participants will be randomly assigned to OA CARE or a usual care (UC) group. Assessments will be conducted at baseline, 6 months and 12 months. Primary endpoint of the trial will be self-reported pain and function and secondary endpoint will be objectively assessed physical activity (PA), measured via accelerometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinician diagnosis of knee or hip OA
- •Self-reported knee or hip pain of ≥3 (scale of 0-10) on most days of the week
- •Current Weekly Physical Activity <150 minutes per week
- •Body mass index (BMI) ≥27 kg/m^2
排除标准
- •No internet access and a device (computer, tablet, smartphone) to access the virtual weight loss intervention
- •Pain in chest when performing physical activity
- •Pain in chest when not performing physical activity
- •No documented diagnosis of knee or hip OA
- •Total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months
- •Dementia or other memory loss condition
- •Active diagnosis of psychosis
- •Active Substance abuse disorder
- •Severe hearing or visual impairment
- •Serious/terminal illness as indicated by referral to hospice or palliative care
- •Hospitalization for cardiovascular event in last 6 months
- •History of ventricular tachycardia
- •Unstable chronic obstructive pulmonary disease (2 hospitalizations within the previous 6 months and/or on oxygen)
- •Stroke with moderate to severe aphasia
- •Recent history (last 6 months) of three or more falls
- •Planning total joint replacement in next 6 months
- •Any other health conditions determined by the study team to be contraindications to a home exercise program or weight loss
- •Current participation in other study related to knee or hip osteoarthritis or physical activity
- •Unable to speak English
研究组 & 干预措施
OA CARE
Participants assigned to the OA CARE intervention will receive a 12-month Medical Membership to a local YMCA and participate in a 12-week weight loss program. Participants will also work with an OA CARE Navigator, who, in partnership with their primary care provider (PCP), will identify any additional programs or resources that may help them manage their osteoarthritis (OA) symptoms.
干预措施: OA CARE Intervention (Behavioral)
Usual Care
Participants assigned to this group will receive no additional treatment from the study for about 12 months.
干预措施: Usual Care control group (Behavioral)
结局指标
主要结局
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
时间窗: Baseline, Month 6 (Follow-up)
For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations.
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
时间窗: Baseline, Month 12 (Follow-up)
For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations.
次要结局
- Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale(Baseline, Month 6 (Follow-up))
- Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale(Baseline, Month 12 (Follow-up))
- Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale(Baseline, Month 6 (Follow-up))
- Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale(Baseline, Month 12 (Follow-up))
- Change From Baseline to Month 6 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed.(Baseline, Month 6 (Follow-up))
- Change From Baseline to Month 12 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed(Baseline, Month 12 (Follow-up))
- Change From Baseline to Month 6 in Steps Per Day, Log Transformed(Baseline, Month 6 (Follow-up))
- Change From Baseline to Month 12 in Steps Per Day, Log Transformed(Baseline, Month 12 (Follow-up))
- Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) Per Day, Standardized to a 16 Hour Day(Baseline, Month 6 (Follow-up))
- Change From Baseline to Month 12 in Minutes of Any Physical Activity (PA) Per Day, Standardized to 16 Hour Day(Baseline, Month 12 (Follow-up))
- Change From Baseline to Month 6 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed(Baseline, Month 6 (Follow-up))
- Change From Baseline to Month 12 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed(Baseline, Month 12 (Follow-up))
- Change From Baseline to Month 6 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day(Baseline, Month 6 (Follow-up))
- Change From Baseline to Month 12 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day(Baseline, Month 12 (Follow-up))
- Change From Baseline to Month 12 in Body Weight(Baseline, Month 12 (Follow-up))
- Change From Baseline to Month 12 in 30-second Chair Stand Test(Baseline, Month 12 (Follow-up))
- Change From Baseline to Month 12 in Timed Up-and-go (TUG) Test(Baseline, Month 12 (Follow-up))
- Change From Baseline to Month 12 in 2-minute March Test(Baseline, Month 12 (Follow-up))