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

Not Applicable

Completed

• Conditions: Scleroderma
• Interventions: Behavioral: Resilience-based, Energy Management to Enhance Wellbeing (RENEW)

• Registration Number: NCT04588714
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Study Start: 2020-10-27
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Resilience-based, Energy Management to Enhance Wellbeing (RENEW)	Resilience-based, Energy Management to Enhance Wellbeing (RENEW)	RENEW is a 12-week program in which participants are paired with a peer mentor who serves as their health coach throughout the intervention period. The website serves as the program "workbook" to help promote skill practice and attainment in areas like goal setting, pacing, relaxation, etc.

Primary Outcome Measures

Name	Time	Method
Feasibility as assessed by intervention participant retention	12 weeks	Number of participants who complete the study
Feasibility as assessed by the participation in intervention related phone calls	12 weeks	Number of completed peer-mentor calls

Secondary Outcome Measures

Name	Time	Method
Feasibility as assessed by the time spent in preparation for intervention phone calls	12 weeks	Preparation time of peer mentors will be documented in minutes.
Feasibility as assessed by active participant involvement	12 weeks	Number of minutes spent accessing the RENEW website/app
Feasibility as assessed by the peer mentor health coach time	12 weeks

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States