Systemic Sclerosis
Conditions
Brief 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 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.
Interventions
DEVICERENEW
The RENEW program is 12-week program where participants are asked to access the app and set and track weekly healthy goals.
Sponsors
University of Michigan
Shepherd Center, Atlanta GA
National Institute on Disability, Independent Living, and Rehabilitation Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility based on study recruitment rate | 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 | 12 weeks | Number of participants who complete the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RENEW participation - website | 12 weeks | Reported as the number of minutes spent accessing the RENEW app |
| Acceptability | 12 weeks | Assessed using the 12-week feedback questionnaire |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSusan Murphy, ScD, OTR
University of Michigan
Outcome results
None listed