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

• ClinicalTrials.gov Identifier: NCT04908943
• Recruitment Status: Completed
• First Posted: June 1, 2021
• Last Update Posted: November 30, 2023
• Sponsor: University of Michigan
• Collaborator: Rheumatology Research Foundation
• Information provided by (Responsible Party): Susan Murphy, University of Michigan

Tracking Information

• First Submitted Date: May 26, 2021
• First Posted Date: June 1, 2021
• Last Update Posted Date: November 30, 2023
• Actual Study Start Date: August 28, 2021
• Actual Primary Completion Date: May 29, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 26, 2021)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 26, 2021)

• 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.
• 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).
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue
• Official Title: RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Scleroderma

Intervention

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.

Study Arms

• 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.
  Intervention: Behavioral: RENEW
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 18, 2023): 174
• Original Estimated Enrollment (submitted: May 26, 2021): 168
• Actual Study Completion Date: May 29, 2023
• Actual Primary Completion Date: May 29, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04908943
• Other Study ID Numbers: HUM00195121
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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/

• Current Responsible Party: Susan Murphy, University of Michigan
• Original Responsible Party: Susan Murphy, University of Michigan, Associate Professor of Physical Medicine and Rehabilitation and Research
• Current Study Sponsor: University of Michigan
• Original Study Sponsor: Same as current
• Collaborators: Rheumatology Research Foundation

Investigators

• Principal Investigator: Susan Murphy; University of Michigan

• PRS Account: University of Michigan
• Verification Date: November 2023