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

Scleroderma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04588714
• Other study ID #: HUM00186877
• Status: Completed
• Phase: N/A
• Start date: October 27, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed by intervention participant retention	Number of participants who complete the study	12 weeks
Primary	Feasibility as assessed by the participation in intervention related phone calls	Number of completed peer-mentor calls	12 weeks
Secondary	Feasibility as assessed by active participant involvement	Number of minutes spent accessing the RENEW website/app	12 weeks
Secondary	Feasibility as assessed by the peer mentor health coach time		12 weeks
Secondary	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