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

Study Overview
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Brief Summary
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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.

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

Conditions
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Scleroderma

Intervention / Treatment
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* Behavioral: Resilience-based, Energy Management to Enhance Wellbeing (RENEW)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study, one arm, pre-test, post-test trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peer mentor, Web-based