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

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.

Study Overview

• Status: Completed
• Conditions: Scleroderma
• Intervention / Treatment: Behavioral: RENEW

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Rheumatology Research Foundation
• Investigators: Principal Investigator: Susan Murphy, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2021
• Primary Completion (Actual): May 29, 2023
• Study Completion (Actual): May 29, 2023

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Systemic Sclerosis
• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
• Other Study ID Numbers: HUM00195121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Data will be available beginning 9 months and ending 36 month after publication of primary analyses.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No