Systemic SclerosisRENEWNCT07402863
Self-Guided Resilience-Building Energy Management to Enhance Well-being (RENEW) Intervention for People With Systemic Sclerosis (SSc)
A study testing RENEW in people with Systemic Sclerosis, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this clinical trial is to gather information on the RENEW app used by people with scleroderma. Specifically, the researchers want to learn more about RENEW by collecting information about the rates of recruitment, retention of study participants information about study completion, and time spent accessing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- RENEW
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2025to 28 Jul 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
- Have a diagnosis of systemic sclerosis including: diffuse cutaneous SSc, limited cutaneous SSc, overlap, or SINE
- Have access to a reliable, internet-connected device (e.g. smartphone or tablet)
- Be able to read, speak, and understand English
- Participants need to report a score of at least 4 on a scale of 0 - 10 of fatigue severity, a cut-off for at least moderate fatigue in other fatiguing conditions1
Who cannot join
- Complex, unstable health issues that would preclude full participation in the study
- Planning to start new treatment for fatigue, pain, mood during the study period
- Previous experience with RENEW app or past participant of RENEW
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Guided Resilience-Building Energy Management to Enhance Well-being Intervention for People With Systemic Sclerosis: A Feasibility Study
The goal of this clinical trial is to gather information on the RENEW app used by people with scleroderma. Specifically, the researchers want to learn more about RENEW by collecting information about the rates of recruitment, retention of study participants information about study completion, and time spent accessing the app content.
Read the detailed description
RENEW is Institutional Review Board approved as a non-significant risk device but it not subject to 510(k) and therefore not regulated by the FDA.
- Conditions
- Systemic Sclerosis
- Being tested
- RENEW
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RENEWDevice
The RENEW program is 12-week program where participants are asked to access the app and set and track weekly healthy goals.
| Study group | Role | What they receive |
|---|---|---|
| RENEW | Experimental | Individuals with SSc who are interested and eligible will undergo an informed consent process and will be given access to the RENEW program via the app Receives: Device: RENEW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility based on study recruitment rate
Number of participants enrolled (over 3 months) divided by the number of individuals who were eligible to participate
Measured: 12 weeks
Feasibility based on study retention
Number of participants who complete the study
Measured: 12 weeks
Secondary outcomes (2)
RENEW participation - website
Reported as the number of minutes spent accessing the RENEW app
Measured: 12 weeks
Acceptability
Assessed using the 12-week feedback questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start28 Jan 2025
- Primary completion28 Apr 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Shepherd Center, Atlanta GA, National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Susan Murphy, University of Michigan
- Investigators
- Susan Murphy, ScD, OTR, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402863
- Sponsor's protocol ID
- HUM00266174
- Other IDs
- SHEP-20-0010, 90DPHF0004
- Acronym
- RENEW
- Status last verified
- Apr 2026
- First submitted
- 21 Jan 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen YT, Harper AE, Alore M, Haro E, Morris JT, Khanna D, Murphy SL. 'It helps me stay on track': patient experiences using a mobile app for self-management of systemic sclerosis with a focus on fatigue in women. Rheumatol Adv Pract. 2026 Aug 13;10(3):rkag102. doi: 10.1093/rap/rkag102. eCollection 2026.
PubMed 42677336
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Guided Resilience-Building Energy Management to Enhance Well-being Intervention for People With Systemic Sclerosis: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07402863
- Acronym / sponsor ID
- RENEW / HUM00266174
- Conditions
- Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Shepherd Center, Atlanta GA, National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 11 Feb 2026 (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 goal of this clinical trial is to gather information on the RENEW app used by people with scleroderma. Specifically, the researchers want to learn more about RENEW by collecting information about the rates of recruitment, retention of study participants information about study completion, and time spent accessing the app content.
Detailed description
RENEW is Institutional Review Board approved as a non-significant risk device but it not subject to 510(k) and therefore not regulated by the FDA.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RENEW | Experimental | Device: RENEWIndividuals with SSc who are interested and eligible will undergo an informed consent process and will be given access to the RENEW program via the app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a diagnosis of systemic sclerosis including: diffuse cutaneous SSc, limited cutaneous SSc, overlap, or SINE
- Have access to a reliable, internet-connected device (e.g. smartphone or tablet)
- Be able to read, speak, and understand English
- Participants need to report a score of at least 4 on a scale of 0 - 10 of fatigue severity, a cut-off for at least moderate fatigue in other fatiguing conditions1
Key exclusion criteria (3 listed)
- Complex, unstable health issues that would preclude full participation in the study
- Planning to start new treatment for fatigue, pain, mood during the study period
- Previous experience with RENEW app or past participant of RENEW
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 |
|---|---|---|
| RENEWThe RENEW program is 12-week program where participants are asked to access the app and set and track weekly healthy goals. | Device | RENEW |
Primary outcome
Feasibility based on study recruitment rate
Time frame: 12 weeks
Number of participants enrolled (over 3 months) divided by the number of individuals who were eligible to participate
Feasibility based on study retention
Time frame: 12 weeks
Number of participants who complete the study
2 secondary outcomes
RENEW participation - website
Time frame: 12 weeks
Acceptability
Time frame: 12 weeks
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 1 May 2026.
- Derived from this study: PubMed 42677336Chen YT, Harper AE, Alore M, Haro E, Morris JT, Khanna D, Murphy SL. 'It helps me stay on track': patient experiences using a mobile app for self-management of systemic sclerosis with a focus on fatigue in women. Rheumatol Adv Pract. 2026 Aug 13;10(3):rkag102. doi: 10.1093/rap/rkag102. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
Susan Murphy, ScD, OTR 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 in people with Systemic Sclerosis, 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 4 inclusion and 3 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 1 May 2026. 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?
Feasibility based on study recruitment rate (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07402863, which also lists 1 linked publication.
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 1 May 2026.