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

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.

Study Overview

• Status: Completed
• Conditions: Scleroderma
• Intervention / Treatment: Behavioral: Resilience-based, Energy Management to Enhance Wellbeing (RENEW)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Resilience-based, Energy Management to Enhance Wellbeing (RENEW); The program includes unlimited website access and 10 scheduled phone calls with an assigned peer mentor.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as assessed by active participant involvement	Number of minutes spent accessing the RENEW website/app	12 weeks
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	Preparation time of peer mentors will be documented in minutes.	12 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Dinesh Khanna, MD, MS, University of Michigan; Principal Investigator: Susan Murphy, ScD, OTR/L, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Web-based; Peer mentor
• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: HUM00186877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No