Mobilizing Hispanics With Knee Osteoarthritis Using a Dyad-based Approach: Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Educational sessions attended
研究概览
简要总结
The objective is to conduct an early-stage clinical trial in order to provide data required to support a future clinical trial to demonstrate the effectiveness of a culturally acceptable treatment program to increase exercise and regular physical activity among Hispanics with knee osteoarthritis (OA).
Hispanic patients with knee OA paired with a chosen family member/close friend will be recruited for study participation. A pilot randomized controlled trial will be conducted. Study pairs will be randomized to receive either: 1) an intervention that will be administered by live video consultations and will include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving study pairs; or 2) a control treatment that only includes live video educational sessions about OA.
Study participants will fill out a survey before the start of the study and 3 months after.
详细描述
Feasibility of the intervention will be based on the number of study pairs that will be recruited during the study and on attendance to the intervention sessions, and acceptability will be based on quantitative acceptability (e.g., program satisfaction) and qualitative measures.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hispanic/Latino ethnicity
- •≥ 50 years of age
- •Access to a device with internet connection
- •Chronic, frequent knee pain (National Health and Nutrition Examination Survey criteria)
- •Meet American College of Rheumatology criteria for knee OA WOMAC pain score of ≥4 and at least moderate pain (score 2) for at least 2 questions
排除标准
- •Unknown or non-Hispanic ethnicity
- •Condition that prevents ability to provide consent
- •Illness with a life expectancy <12 months
- •History of arthroplasty or prosthetic leg
- •Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, gout)
- •Condition that prevents exercise or physical activity (e.g., unstable cardiovascular disease)
研究组 & 干预措施
Intervention
Treatments include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving dyads
干预措施: Muscle Strengthening (Behavioral)
Intervention
Treatments include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving dyads
干预措施: General Physical Activity (Behavioral)
Control
Treatment only includes live video educational sessions about OA
干预措施: Education (Behavioral)
Intervention
Treatments include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving dyads
干预措施: Education (Behavioral)
结局指标
主要结局
Educational sessions attended
时间窗: 3 month follow-up
Number of educational sessions attended by patients and partners will be recorded
Adherence with muscle strengthening program
时间窗: 3 month follow-up
Intervention group only. Patients will rate how much they agree/disagree (11-point numerical rating scale) with the statement: "I have been doing my exercises exactly as I was asked by my physical therapist (# sessions, exercises and repetitions)".
Perceived helpfulness
时间窗: 3 month follow-up
Perceived helpfulness of the program/s in improving OA symptoms, increasing physical activity and improving communication with their chosen partner, and the likelihood of recommending the program to OA patients and their partners, using a 5-point numerical rating scale (1=not at all/definitely would not, 5=extremely/definitely would not)
Satisfaction with program
时间窗: 3 month follow-up
Satisfaction with the program/s, using a 7-point numerical rating scale (1="extremely unsatisfied", 7="extremely satisfied")
Adherence with physical activity plan
时间窗: 3 month follow-up
Intervention group only. Study dyads will rate how much they agree/disagree in an 11-point numerical rating scale with the statement: "I followed the physical activity plan that my promotora helped me develop".
次要结局
- Physical activity(Baseline and 3 month follow-up)
- Physical activity (self-report)(Baseline and 3 month follow-up)
- Osteoarthritis disease severity(Baseline and 3 month follow-up)