RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 174
- Locations
- 2
- Primary Endpoint
- Change in Fatigue
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Masking Description
Participants and study team member who randomizes participants are blinded to participant responses at randomization. However, following assignment the blind is broken.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.)
Outcomes
Primary Outcomes
Change in Fatigue
Time Frame: 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.
Secondary Outcomes
- Change in Pain Interference(Up to 12 weeks)
- Change in Resilience(Up to 12 weeks)
- Change in Depressive symptoms(Up to 12 weeks)
Investigators
Susan Murphy
Professor of Physical Medicine and Rehabilitation and Research
University of Michigan