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

NCT06999226 | Completed

• 1 other identifier: HUM00257292
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma

Keywords

Systemic Sclerosis

Outcome Measures

Primary Outcomes (3)

• Engagement with the AI chat feature

  Engagement is measured through app analytics (It will be reported as the proportion of participants who use the chat feature.)

  Up to 4 weeks

• Satisfaction with AI-generated health coaching

  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

  4 weeks

• Acceptability of RENEW

  Assessed via focus groups

  4 weeks

Other Outcomes (4)

• Change in Fatigue

  Baseline, week 4

• Change in Pain interference

  Baseline, week 4

• Change in Depressive symptoms

  Baseline, week 4

Study Arms (1)

RENEW-AI Chat arm

EXPERIMENTAL

Participants (n=20) who participated in the original RENEW trial will get access to a chat functionality within the RENEW app. The chat functionality in the RENEW app is powered by a large language model and tailored using prompt engineering techniques.

Behavioral: RENEW-AI

Interventions

RENEW-AI BEHAVIORAL

AI assisted health coaching using the LLM-driven chat functionality.

RENEW-AI Chat arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

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

Study Officials

• Nirali Shah

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Susan Murphy

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study team members who interact with participants during the enrollment process will be blinded to participant feedback provided during the study to avoid any influence on the participants' experience or outcomes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow, Physical Medicine and Rehabilitation

Model Details: Phase 2 will involve a single-arm, pre-post study design where 20 participants of the original RENEW trial will use the NLP-chat feature integrated into the RENEW app over a 4-week period.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: May 19, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)