Clinical trial NCT06999226: RENEW-AI: Personalizing Scleroderma Management With an AI Health Coach
Official title: RENEW-AI: Personalizing Scleroderma Management With an AI Health Coach
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Scleroderma
Keywords: Systemic Sclerosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Engagement with the AI chat feature
timeFrame: Up to 4 weeks
measure: Satisfaction with AI-generated health coaching
timeFrame: 4 weeks
measure: Acceptability of RENEW
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
measure: Change in Fatigue
timeFrame: Baseline, week 4
measure: Change in Pain interference
timeFrame: Baseline, week 4
measure: Change in Depressive symptoms
timeFrame: Baseline, week 4
measure: Change in Resilience
timeFrame: Baseline, week 4
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Nirali Shah
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Susan Murphy
role: PRINCIPAL_INVESTIGATOR
References: