CompletedNot Applicable

Self-Guided Resilience-Building Energy Management to Enhance Well-being (RENEW) Intervention for People With Systemic Sclerosis (SSc)

United States43 participantsStarted 2025-01-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility based on study recruitment rate

Timeframe: 12 weeks

Feasibility based on study retention

Timeframe: 12 weeks

Trial details

NCT IDNCT07402863

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-28

View on ClinicalTrials.gov More Systemic Sclerosis trials