Skip to main content
OpenTrials
Completed

NCT Number: NCT07402863

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RENEW

Device

The RENEW program is 12-week program where participants are asked to access the app and set and track weekly healthy goals.

Primary outcomes

  1. 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

  2. Feasibility based on study retention

    Time frame: 12 weeks

    Number of participants who complete the study

Secondary outcomes

  1. RENEW participation - website

    Time frame: 12 weeks

    Reported as the number of minutes spent accessing the RENEW app

  2. Acceptability

    Time frame: 12 weeks

    Assessed using the 12-week feedback questionnaire

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research
  • Shepherd Center, Atlanta GA

Registry information

Official study title

Self-Guided Resilience-Building Energy Management to Enhance Well-being Intervention for People With Systemic Sclerosis: A Feasibility Study

Acronym: RENEW

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.