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RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04908943
Recruitment Status : Completed
First Posted : June 1, 2021
Last Update Posted : November 30, 2023
Sponsor:
Collaborator:
Rheumatology Research Foundation
Information provided by (Responsible Party):
Susan Murphy, University of Michigan

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Scleroderma Behavioral: RENEW Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Participants and study team member who randomizes participants are blinded to participant responses at randomization. However, following assignment the blind is broken.
Primary Purpose: Supportive Care
Official Title: RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue
Actual Study Start Date : August 28, 2021
Actual Primary Completion Date : May 29, 2023
Actual Study Completion Date : May 29, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Scleroderma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW)
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.
 Behavioral: RENEW
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.
No Intervention: Waitlist
Participants will be asked about changes in health status, and use of any new treatments or services at 6 and 12 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Fatigue [ Time Frame: Up to 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in Pain Interference [ Time Frame: Up to 12 weeks ]
    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.

  2. Change in Resilience [ Time Frame: Up to 12 weeks ]
    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).

  3. Change in Depressive symptoms [ Time Frame: Up to 12 weeks ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of Systemic Sclerosis (SSc), any subtype
  • Report a mean score of at least 4 on the Fatigue Severity Scale; potential mean range 1-9
  • Have access to a computer and an internet connection
  • Are able to speak and read English.

Exclusion Criteria:

  • Currently undergoing structured rehabilitation or psychological treatment.
  • Other issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to access RENEW intervention, etc.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04908943


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Rheumatology Research Foundation
Investigators
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Principal Investigator: Susan Murphy University of Michigan
More Information
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Responsible Party: Susan Murphy, Professor of Physical Medicine and Rehabilitation and Research, University of Michigan
ClinicalTrials.gov Identifier: NCT04908943    
Other Study ID Numbers: HUM00195121
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: November 30, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant de-identified data that underlie the results reported in the article will be shared with researchers who present a methodologically sound proposal.
Supporting Materials: Study Protocol
Time Frame: Data will be available beginning 9 months and ending 36 month after publication of primary analyses.
Access Criteria: 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
URL: http://www.icpsr.umich.edu/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susan Murphy, University of Michigan:
Systemic Sclerosis
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases