RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Change in Fatigue
研究概览
简要总结
The researchers seek to understand if the Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) program helps with scleroderma symptom management and disease burden. The researchers think that those participants who receive the intervention will have clinically meaningful changes of symptom management and disease burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants and study team member who randomizes participants are blinded to participant responses at randomization. However, following assignment the blind is broken.
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
- •Have a diagnosis of Systemic Sclerosis (SSc), any subtype
- •Report a mean score of at least 4 on the Fatigue Severity Scale; potential mean range 1-9
- •Have access to a computer and an internet connection
- •Are able to speak and read English.
排除标准
- •Currently undergoing structured rehabilitation or psychological treatment.
- •Other issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to access RENEW intervention, etc.)
研究组 & 干预措施
Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW)
RENEW was created by researchers, doctors, and patients with scleroderma. It is a web-based peer-led program to help manage energy and symptoms in people who have scleroderma.
干预措施: RENEW (Behavioral)
Waitlist
Participants will be asked about changes in health status, and use of any new treatments or services at 6 and 12 weeks.
结局指标
主要结局
Change in Fatigue
时间窗: Up to 12 weeks
Fatigue is measured by The Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue 13a. FACIT is a questionnaire with 13 questions and a score ranging from 13-65. Higher scores indicate greater fatigue.
次要结局
- Change in Pain Interference(Up to 12 weeks)
- Change in Resilience(Up to 12 weeks)
- Change in Depressive symptoms(Up to 12 weeks)
研究者
Susan Murphy
Professor of Physical Medicine and Rehabilitation and Research
University of Michigan