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

April 27, 2026 updated by: Susan Murphy, University of Michigan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: RENEW
The RENEW program is 12-week program where participants are asked to access the app and set and track weekly healthy goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
Feasibility based on study retention
Time Frame: 12 weeks
Number of participants who complete the study
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RENEW participation - website
Time Frame: 12 weeks
Reported as the number of minutes spent accessing the RENEW app
12 weeks
Acceptability
Time Frame: 12 weeks
Assessed using the 12-week feedback questionnaire
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

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

Investigators

  • Principal Investigator: Susan Murphy, ScD, OTR, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2025

Primary Completion (Actual)

April 28, 2025

Study Completion (Actual)

July 28, 2025

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00266174
  • SHEP-20-0010 (Other Grant/Funding Number: Shepherd Center, Inc., Atlanta, Georgia)
  • 90DPHF0004 (Other Grant/Funding Number: National Institute on Disability, Independent Living and Rehabilitation Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Sclerosis

Clinical Trials on RENEW

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe