Physical Activity Pathway for Patients With Osteoarthritis in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)
研究概览
简要总结
The purpose of this study is to test an osteoarthritis (OA) primary care Physical activity Care Pathway (OA-PCP), a scalable intervention that includes: 1) a practical process for physical inactivity screening in primary care, 2) a brief, tailored physical activity (PA) counseling intervention via telephone, 3) connection of patients with community programs and other resources to support PA, and 4) follow-up with patients to deliver additional appropriate counseling and referrals to PA resources. This program will be compared to another program that provides education on a variety of topics important to understanding osteoarthritis (OA) and its care.
详细描述
This study will be a randomized pilot trial of the refined OA-PCP among n=240 patients age ≥65 with hip and/or knee OA recruited from primary care clinics. Participants will be assigned equally to either the OA-PCP or an attention control group. Participants will complete assessments at baseline, and 6-month and 12-month follow-up. Primary endpoint of the trial will be objectively assessed PA, measured via accelerometer and secondary endpoint will be self-reported pain and function.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 or older
- •One other chronic health condition that qualified under Chronic Care Management (CCM) guidelines, including: diabetes, depression, hypertension, hyperlipidemia, heart failure, atrial fibrillation, ischemic heart disease, stroke/transient ischemic attack (TIA), peripheral vascular disease, Chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, rheumatoid arthritis, osteoarthritis, HIV/AIDS, chronic kidney disease, hepatitis (chronic & viral B & C) and osteoporosis
- •Current Joint Symptoms
- •Self-reported physical activity <150 minutes per week
- •Willing to make a change in PA over the next 3 months
排除标准
- •Pain in chest when performing physical activity
- •Pain in chest when not performing physical activity
- •Loss of balance because of dizziness or loss of consciousness
- •Recommendation from doctor to only perform physical activity under medical supervision
- •No documented diagnosis of knee or hip OA
- •Dementia or other memory loss condition
- •Active diagnosis of psychosis
- •Active Substance abuse disorder
- •Total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months
- •Severe hearing or visual impairment
- •Serious/terminal illness as indicated by referral to hospice or palliative care
- •Unstable angina
- •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
结局指标
主要结局
Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)
时间窗: Baseline, Month 6 (Follow-up)
Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer
Change From Baseline to Month 12 for Minutes in Objectively Assessed Physical Activity (Accelerometer)
时间窗: Baseline, Month 12 (Follow-up)
Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer
次要结局
- Change From Baseline to Month 6 for Steps Per Day(Baseline, Month 6 (Follow-up))
- Change From Baseline to Month 6 for Minutes of Sedentary Activity(Baseline, Month 6 (Follow-up))
- Change From Baseline to Month 12 for Minutes of Sedentary Activity(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 Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale(Baseline, Month 6 (Follow-up))
- Change From Baseline to Month 12 for Steps Per Day(Baseline, Month 12 (Follow-up))
- Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale(Baseline, Month 12 (Follow-up))