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OpenTrials
Completed

NCT Number: NCT04908943

RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue

The researchers seek to understand if the Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) program helps with scleroderma symptom management and disease burden. The researchers think that those participants who receive the intervention will have clinically meaningful changes of symptom management and disease burden.

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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 (SSc), any subtype
  • Report a mean score of at least 4 on the Fatigue Severity Scale; potential mean range 1-9
  • Have access to a computer and an internet connection
  • Are able to speak and read English.

Exclusion criteria

  • Currently undergoing structured rehabilitation or psychological treatment.
  • Other issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to access RENEW intervention, etc.)

Treatment and study plan

RENEW

Behavioral

RENEW is a 12-week, peer-led, web-based program to help people with scleroderma learn skills that can be used to manage disease symptoms and improve well-being.

Primary outcomes

  1. Change in Fatigue

    Time frame: Up to 12 weeks

    Fatigue is measured by The Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue 13a. FACIT is a questionnaire with 13 questions and a score ranging from 13-65. Higher scores indicate greater fatigue.

Secondary outcomes

  1. Change in Pain Interference

    Time frame: Up to 12 weeks

    Pain interference is measured by Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a scale Pain Interference 4a will assess self-reported consequences of pain with 4 questions ranked on a 5-point scale, from "not at all" to "very much". The minimum score is 4 and the maximum score is 20. Lower scores suggest less pain interference.

  2. Change in Resilience

    Time frame: Up to 12 weeks

    Resilience is measured by Connor-Davidson Resilience Scale 10 (CD-RISC-10). It is a 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time). The overall score range from 0 (no resilience) to 40 (High Resilience).

  3. Change in Depressive symptoms

    Time frame: Up to 12 weeks

    Depressive symptoms are measured by PROMIS depression 4a assesses self-reported negative mood (e.g., sadness), views of self (e.g., worthlessness), social cognition (e.g., loneliness), and decreased positive affect and engagement. Items are all answered on a 5-point scale from 1=Never to 5=Always. Scores can range from 0 meaning no anxiety/depression to 40 meaning high

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Rheumatology Research Foundation

Registry information

Acronym: RENEW

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2021
Registry last updated
Nov 30, 2023

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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