Back to resultsRENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW)
Primary Purpose
Scleroderma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RENEW
Sponsored by
About this trial
This is an interventional supportive care trial for Scleroderma focused on measuring Systemic Sclerosis
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.)
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW)
Waitlist
Arm Description
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.
Participants will be asked about changes in health status, and use of any new treatments or services at 6 and 12 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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
Full Information
NCT ID
NCT04908943
First Posted
May 26, 2021
Last Updated
June 7, 2023
Sponsor
University of Michigan
Collaborators
Rheumatology Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04908943
Brief Title
RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue
Acronym
RENEW
Official Title
RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 28, 2021 (Actual)
Primary Completion Date
May 29, 2023 (Actual)
Study Completion Date
May 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Rheumatology Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma
Keywords
Systemic Sclerosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Participants and study team member who randomizes participants are blinded to participant responses at randomization. However, following assignment the blind is broken.
Allocation
Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW)
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Participants will be asked about changes in health status, and use of any new treatments or services at 6 and 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
RENEW
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Fatigue
Description
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.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Change in Pain Interference
Description
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.
Time Frame
Up to 12 weeks
Title
Change in Resilience
Description
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).
Time Frame
Up to 12 weeks
Title
Change in Depressive symptoms
Description
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
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Murphy
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue
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