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

University of Michigan1 site in 1 country174 target enrollmentAugust 28, 2021

ConditionsScleroderma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Scleroderma
Sponsor: University of Michigan
Enrollment: 174
Locations: 1
Primary Endpoint: Change in Fatigue
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 28, 2021

End Date

May 29, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

Susan Murphy

Professor of Physical Medicine and Rehabilitation and Research

University of Michigan

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.)

Outcomes

Primary Outcomes

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.