Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention

University of Michigan1 site in 1 country21 target enrollmentOctober 27, 2020

ConditionsScleroderma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Scleroderma
Sponsor: University of Michigan
Enrollment: 21
Locations: 1
Primary Endpoint: Feasibility as assessed by intervention participant retention
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have scleroderma. Resilience-based, Energy Management to Enhance Wellbeing (RENEW) was created by researchers, doctors, and patients with scleroderma. The goal is to help people with scleroderma feel better.

Registry

clinicaltrials.gov

Start Date

October 27, 2020

End Date

May 31, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

Susan Murphy

Associate Professor of Physical Medicine and Rehabilitation and Research Associate Professor, Institute of Gerontology, Medical School

University of Michigan

Eligibility Criteria

Inclusion Criteria

•Have a diagnosis of systemic sclerosis including:
•Diffuse or limited cutaneous
•Have access to a reliable, internet-connected device (e.g. computer, tablet)
•Be able to read, speak, and understand English
•Participants need to report a score of at least 4 on a scale of 0 - 10 of fatigue severity, a cut-off for at least moderate fatigue in other fatiguing conditions.

Exclusion Criteria

•Complex, unstable health issues that would preclude full participation in the study
•Planning to start new treatment for fatigue, pain, mood during the study period

Outcomes

Primary Outcomes

Feasibility as assessed by intervention participant retention

Time Frame: 12 weeks

Number of participants who complete the study

Feasibility as assessed by the participation in intervention related phone calls

Time Frame: 12 weeks

Number of completed peer-mentor calls

Secondary Outcomes

Feasibility as assessed by the peer mentor health coach time(12 weeks)
Feasibility as assessed by the time spent in preparation for intervention phone calls(12 weeks)
Feasibility as assessed by active participant involvement(12 weeks)