RENEW-AI: Personalizing Scleroderma Management With an AI Health Coach

Not Applicable

• Conditions: Scleroderma

• Registration Number: NCT06999226
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of this pilot study is to explore the use of a large language model (LLM) in providing education and behavioral health coaching for individuals with Systemic Sclerosis (SSc). The goal of the LLM is to help user set or modify behavioral goals, provide education, or emotional support as needed by the participant. The primary outcome for this study is to assess the feasibility and acceptability of using an AI-supported health coaching tool over a four-week period.

Detailed Description

The study is supported by Dan Barry Trainee Research Program through the Department of Physical Medicine and Rehabilitation at Michigan Medicine.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-19
• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Participants from our previous clinical trial, who received the original RENEW intervention (n=66), will be invited to participate in this study.
• Participants who have a medical diagnosis of systemic sclerosis, any subtype (diffuse, limited, Sine, or overlap)
• Participants who report a mean score 4 or more on the Fatigue Severity Scale, indicative of problematic fatigue; potential mean range 1-9
• Participants who have access to a computer and an internet connection
• Participants who are able to speak and read English.

Exclusion Criteria

• Individuals who did not participate in the original RENEW trial
• Individuals who lack access to reliable high-speed internet will be excluded to ensure they can fully engage with the AI-supported health coaching and digital components of the study
• Non-English speakers will be excluded because the current version of the AI tool is available only in English
• Individuals planning to initiate any new treatments specifically targeting fatigue, pain, or mood symptoms (such as psychological therapy, structured rehabilitation, or new medications) during the 4-week study period will be excluded, to avoid confounding effects on the study outcomes.
• Individuals with other significant medical or logistical issues that would impede meaningful participation, such as severe concurrent medical conditions, inability to access the RENEW intervention, or cognitive impairments that prevent them from engaging with study procedures, will also be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Engagement with the AI chat feature	Up to 4 weeks	Engagement is measured through app analytics (It will be reported as the proportion of participants who use the chat feature.)
Satisfaction with AI-generated health coaching	4 weeks	Satisfaction is self-reported on the mhealth satisfaction survey v 1. It is a 14-item survey with Likert like questions ranging from 1, strongly disagree to 5, strongly agree. Higher scores imply more satisfaction
Acceptability of RENEW	4 weeks	Assessed via focus groups

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States