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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06999226
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Michigan
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Nirali ShahSusan Murphy
Principal Investigator Affiliation University of MichiganUniversity of Michigan
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Scleroderma
Additional Details

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

Arms & Interventions

Arms

Experimental: RENEW-AI Chat arm

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.

Interventions

Behavioral: - RENEW-AI

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Michigan, Ann Arbor, Michigan

Status

Address

University of Michigan

Ann Arbor, Michigan, 48109

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