Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SHEP-20-0010 | Other Grant/Funding Number | Shepherd Center, Inc., Atlanta, Georgia | |
| 90DPHF0004 | Other Grant/Funding Number | National Institute on Disability, Independent Living and Rehabilitation Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shepherd Center, Atlanta GA | OTHER |
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RENEW | Device | The RENEW program is 12-week program where participants are asked to access the app and set and track weekly healthy goals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility based on study recruitment rate | Number of participants enrolled (over 3 months) divided by the number of individuals who were eligible to participate | 12 weeks |
| Feasibility based on study retention | Number of participants who complete the study | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| RENEW participation - website | Reported as the number of minutes spent accessing the RENEW app | 12 weeks |
| Acceptability | Assessed using the 12-week feedback questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan Murphy, ScD, OTR | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 20, 2025 | Feb 27, 2026 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 weeks |