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| Name | Class |
|---|---|
| Rheumatology Research Foundation | OTHER |
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The researchers seek to understand if the Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) program helps with scleroderma symptom management and disease burden. The researchers think that those participants who receive the intervention will have clinically meaningful changes of symptom management and disease burden.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) | Experimental | RENEW was created by researchers, doctors, and patients with scleroderma. It is a web-based peer-led program to help manage energy and symptoms in people who have scleroderma. |
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| Waitlist | No Intervention | Participants will be asked about changes in health status, and use of any new treatments or services at 6 and 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RENEW | Behavioral | RENEW is a 12-week, peer-led, web-based program to help people with scleroderma learn skills that can be used to manage disease symptoms and improve well-being. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fatigue | Fatigue is measured by The Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue 13a. FACIT is a questionnaire with 13 questions and a score ranging from 13-65. Higher scores indicate greater fatigue. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Interference | Pain interference is measured by Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a scale Pain Interference 4a will assess self-reported consequences of pain with 4 questions ranked on a 5-point scale, from "not at all" to "very much". The minimum score is 4 and the maximum score is 20. Lower scores suggest less pain interference. | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Murphy | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38910596 | Derived | Chen YT, Hassett AL, Khanna D, Murphy SL. Resilience partially mediates the association between perceived social isolation and life satisfaction in people with systemic sclerosis. J Scleroderma Relat Disord. 2024 Jun;9(2):154-161. doi: 10.1177/23971983241232853. Epub 2024 Mar 5. | |
| 38622109 | Derived | Chen YT, Hassett AL, Huang S, Khanna D, Murphy SL. Peer-Led Symptom Management Intervention to Enhance Resilience in People With Systemic Sclerosis: Mediation Analysis From a Randomized Clinical Trial. Arthritis Care Res (Hoboken). 2024 Sep;76(9):1278-1286. doi: 10.1002/acr.25352. Epub 2024 May 31. |
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Individual participant de-identified data that underlie the results reported in the article will be shared with researchers who present a methodologically sound proposal.
Data will be available beginning 9 months and ending 36 month after publication of primary analyses.
Proposals should be directed to sumurphy@med.umich.edu. To gain access, data requesters will need to sign a data use agreement at which time the researchers will provide access to the dataset. After 36 months, data will be deposited at the Inter-university Consortium for Political and Social Research (ICPSR) at the University of Michigan
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| ID | Term |
|---|---|
| D045743 | Scleroderma, Diffuse |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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Participants and study team member who randomizes participants are blinded to participant responses at randomization. However, following assignment the blind is broken.
| Change in Resilience | Resilience is measured by Connor-Davidson Resilience Scale 10 (CD-RISC-10). It is a 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time). The overall score range from 0 (no resilience) to 40 (High Resilience). | Up to 12 weeks |
| Change in Depressive symptoms | Depressive symptoms are measured by PROMIS depression 4a assesses self-reported negative mood (e.g., sadness), views of self (e.g., worthlessness), social cognition (e.g., loneliness), and decreased positive affect and engagement. Items are all answered on a 5-point scale from 1=Never to 5=Always. Scores can range from 0 meaning no anxiety/depression to 40 meaning high | Up to 12 weeks |
| 38618141 | Derived | Chen YT, Harper AE, Phanhdone T, Alore M, Hicks S, Pape A, Jay GM, Bolde S, Feldpausch J, Guetterman TC, Khanna D, Murphy SL. Impact of a resilience-building energy management intervention for people with systemic sclerosis: a mixed methods study. Rheumatol Adv Pract. 2024 Mar 8;8(2):rkae040. doi: 10.1093/rap/rkae040. eCollection 2024. |
| 37846437 | Derived | Murphy SL, Chen YT, Alore M, Hicks S, Pape A, Hassett AL, Kratz AL, Whibley D, Harper AE, Huang S, Jay G, Bolde S, Khanna D. Effects of a Resilience-Building Energy Management Program on Fatigue and Other Symptoms in Systemic Sclerosis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2024 Mar;76(3):318-327. doi: 10.1002/acr.25253. Epub 2024 Jan 12. |