Self-Guided Resilience-Building Energy Management to Enhance Well-being Intervention for People With Systemic Sclerosis: A Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Feasibility based on study retention
Study Overview
Brief Summary
The goal of this clinical trial is to gather information on the RENEW app used by people with scleroderma. Specifically, the researchers want to learn more about RENEW by collecting information about the rates of recruitment, retention of study participants information about study completion, and time spent accessing the app content.
Detailed Description
RENEW is Institutional Review Board approved as a non-significant risk device but it not subject to 510(k) and therefore not regulated by the FDA.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have a diagnosis of systemic sclerosis including: diffuse cutaneous SSc, limited cutaneous SSc, overlap, or SINE
- •Have access to a reliable, internet-connected device (e.g. smartphone or tablet)
- •Be able to read, speak, and understand English
- •Participants need to report a score of at least 4 on a scale of 0 - 10 of fatigue severity, a cut-off for at least moderate fatigue in other fatiguing conditions1
Exclusion Criteria
- •Complex, unstable health issues that would preclude full participation in the study
- •Planning to start new treatment for fatigue, pain, mood during the study period
- •Previous experience with RENEW app or past participant of RENEW
Arms & Interventions
RENEW
Individuals with SSc who are interested and eligible will undergo an informed consent process and will be given access to the RENEW program via the app
Intervention: RENEW (Device)
Outcomes
Primary Outcomes
Feasibility based on study retention
Time Frame: 12 weeks
Number of participants who complete the study
Feasibility based on study recruitment rate
Time Frame: 12 weeks
Number of participants enrolled (over 3 months) divided by the number of individuals who were eligible to participate
Secondary Outcomes
- RENEW participation - website(12 weeks)
- Acceptability(12 weeks)
Investigators
Susan Murphy
Title Professor of Physical Medicine and Rehabilitation, Research Professor, Institute of Gerontology and Professor of Internal Medicine
University of Michigan