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Completed

NCT Number: NCT06999226

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

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.

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Key information

Conditions

Scleroderma Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RENEW-AI

Behavioral

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

Primary outcomes

  1. Engagement with the AI chat feature

    Time frame: Up to 4 weeks

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

  2. Satisfaction with AI-generated health coaching

    Time frame: 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

  3. Acceptability of RENEW

    Time frame: 4 weeks

    Assessed via focus groups

Other outcomes

  1. Change in Fatigue

    Time frame: Baseline, week 4

    Assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue short form (FACIT-F) is a 13 item subscale that allows patient to rate the intensity of their fatigue and its related symptoms on a scale of 0 (not at all) to 4 (very much). The total calculated score varies from 0-52 with a lower score indicating a more severe fatigue level.

  2. Change in Pain interference

    Time frame: Baseline, week 4

    Assessed using the PROMIS Pain Interference short form - 4 item Likert like questions ranging from 1, not at all to 5, very much. Higher scores imply more pain interference

  3. Change in Depressive symptoms

    Time frame: Baseline, week 4

    Assessed using the PROMIS Depression short form - 4 item Likert like questions ranging from 1, never to 5, always Higher scores imply more depression

  4. Change in Resilience

    Time frame: Baseline, week 4

    Assessed using the Connor-Davidson Resilience Scale - 10 item Likert like questions ranging from 0, not true at all to 4, true nearly all the time Higher scores imply more resilience

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 31, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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