REACH (Restore Energy, Activity Can Help) Lupus Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
The goal of this clinical trial is to pilot test the REACH peer coaching program for fatigue in people with systemic lupus erythematosus. The main questions it aims to answer are:
- Is the REACH program feasible and acceptable to participants?
- What is the impact of the REACH program on fatigue?
Researchers will compare the REACH peer coaching program to the REACH mobile health application to see if the REACH program works to reduce fatigue.
Participants will:
- Use the REACH mobile health application to set weekly movement goals and log daily physical activity
- Meet weekly with their REACH peer coach (if they have one) to talk about their movement goals and progress
- Complete weekly symptom surveys
- Complete study surveys when they start the program, in the middle of the program, at the end of the program, and 12 weeks after the program ends
- Participate in an interview to provide feedback on the program
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of systemic lupus erythematosus based on 2019 American College of Rheumatology classification criteria
- •≥ 18 years of age
- •English-speaking
- •Ownership of a smartphone
- •Physician's permission to participate in the study (including engagement in physical activity)
- •Fatigue Severity Scale score ≥ 4
排除标准
- •Inability to consent or comply with the study protocol (cognitively impaired adults).
结局指标
主要结局
Acceptability
时间窗: 12 to 24 weeks
Net Promoter Scores for the educational modules, REACH app, and REACH peer coaching intervention. Interviews exploring the acceptability of study procedures (e.g. data collection methods, study assessments, functionality of the mobile app) and engagement with educational modules and peer coaches.
Feasibility
时间窗: 6 months
Enrollment rates (subjects enrolled/eligible individuals approached).
Adherence
时间窗: 12 months
Proportions of educational modules, activity logs, and coaching sessions completed.
次要结局
- Fatigue(12 weeks and 24 weeks)