SclerodermaNCT06999226
RENEW-AI: Personalizing Scleroderma Management With an AI Health Coach
A study testing RENEW-AI in people with Scleroderma, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma
- What is being tested?
- RENEW-AI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The study is supported by Dan Barry Trainee Research Program through the Department of Physical Medicine and Rehabilitation at Michigan Medicine.
- Conditions
- Scleroderma
- Being tested
- RENEW-AI
- Keywords
- Systemic Sclerosis
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RENEW-AIBehavioural
AI assisted health coaching using the LLM-driven chat functionality.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: RENEW-AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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
Measured: 4 weeks
Acceptability of RENEW
Assessed via focus groups
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start19 May 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirali Mukesh Shah, University of Michigan
- Investigators
- Nirali Shah, Principal investigator, University of MichiganSusan Murphy, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999226
- Sponsor's protocol ID
- HUM00257292
- Status last verified
- Aug 2025
- First submitted
- 22 May 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be shared upon requests to the PI. Requests will be considered on an individual basis.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RENEW-AI: Personalizing Scleroderma Management With an AI Health Coach
- ClinicalTrials.gov ID
- NCT06999226
- Acronym / sponsor ID
- HUM00257292
- Conditions
- Scleroderma
- Keywords
- Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| RENEW-AI Chat arm | Experimental | Behavioral: RENEW-AIParticipants (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RENEW-AIAI assisted health coaching using the LLM-driven chat functionality. | Behavioural | RENEW-AI Chat arm |
Primary outcome
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.)
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
Acceptability of RENEW
Time frame: 4 weeks
Assessed via focus groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No. IPD can be shared upon requests to the PI. Requests will be considered on an individual basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nirali Shah principal investigator
University of Michigan
Susan Murphy principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RENEW-AI in people with Scleroderma, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement with the AI chat feature (time frame: Up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.