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

NCT07402863 | Completed

• 3 other identifiers: HUM00266174SHEP-20-001090DPHF0004
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (2)

• Feasibility based on study recruitment rate

  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

  Number of participants who complete the study

  12 weeks

Secondary Outcomes (2)

• RENEW participation - website

  12 weeks

• Acceptability

  12 weeks

Study Arms (1)

RENEW

EXPERIMENTAL

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

Interventions

RENEW DEVICE

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

RENEW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator
• University of Michigan: lead
• Shepherd Center, Atlanta GA: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Susan Murphy, ScD, OTR

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Title Professor of Physical Medicine and Rehabilitation, Research Professor, Institute of Gerontology and Professor of Internal Medicine

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 11, 2026
• Study Start: January 28, 2025
• Primary Completion: April 28, 2025
• Study Completion: July 28, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)