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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04588714
Other study ID # HUM00186877
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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