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OpenTrials
Completed

NCT Number: NCT04588714

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.

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Key information

Conditions

Scleroderma Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resilience-based, Energy Management to Enhance Wellbeing (RENEW)

Behavioral

The program includes unlimited website access and 10 scheduled phone calls with an assigned peer mentor.

Primary outcomes

  1. Feasibility as assessed by intervention participant retention

    Time frame: 12 weeks

    Number of participants who complete the study

  2. Feasibility as assessed by the participation in intervention related phone calls

    Time frame: 12 weeks

    Number of completed peer-mentor calls

Secondary outcomes

  1. Feasibility as assessed by active participant involvement

    Time frame: 12 weeks

    Number of minutes spent accessing the RENEW website/app

  2. Feasibility as assessed by the peer mentor health coach time

    Time frame: 12 weeks

  3. Feasibility as assessed by the time spent in preparation for intervention phone calls

    Time frame: 12 weeks

    Preparation time of peer mentors will be documented in minutes.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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