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

NCT04908943 | Completed

• 1 other identifier: HUM00195121
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scleroderma

Keywords

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in Fatigue

  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.

  Up to 12 weeks

Secondary Outcomes (3)

• Change in Pain Interference

  Up to 12 weeks

• Change in Resilience

  Up to 12 weeks

• Change in Depressive symptoms

  Up to 12 weeks

Study Arms (2)

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

EXPERIMENTAL

RENEW was created by researchers, doctors, and patients with scleroderma. It is a web-based peer-led program to help manage energy and symptoms in people who have scleroderma.

Behavioral: RENEW

Waitlist

NO INTERVENTION

Participants will be asked about changes in health status, and use of any new treatments or services at 6 and 12 weeks.

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Michigan: lead
• Rheumatology Research Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (4)

• Chen YT, Hassett AL, Khanna D, Murphy SL. Resilience partially mediates the association between perceived social isolation and life satisfaction in people with systemic sclerosis. J Scleroderma Relat Disord. 2024 Jun;9(2):154-161. doi: 10.1177/23971983241232853. Epub 2024 Mar 5.

  PMID: 38910596 DERIVED

• Chen YT, Hassett AL, Huang S, Khanna D, Murphy SL. Peer-Led Symptom Management Intervention to Enhance Resilience in People With Systemic Sclerosis: Mediation Analysis From a Randomized Clinical Trial. Arthritis Care Res (Hoboken). 2024 Sep;76(9):1278-1286. doi: 10.1002/acr.25352. Epub 2024 May 31.

  PMID: 38622109 DERIVED

• Chen YT, Harper AE, Phanhdone T, Alore M, Hicks S, Pape A, Jay GM, Bolde S, Feldpausch J, Guetterman TC, Khanna D, Murphy SL. Impact of a resilience-building energy management intervention for people with systemic sclerosis: a mixed methods study. Rheumatol Adv Pract. 2024 Mar 8;8(2):rkae040. doi: 10.1093/rap/rkae040. eCollection 2024.

  PMID: 38618141 DERIVED

• Murphy SL, Chen YT, Alore M, Hicks S, Pape A, Hassett AL, Kratz AL, Whibley D, Harper AE, Huang S, Jay G, Bolde S, Khanna D. Effects of a Resilience-Building Energy Management Program on Fatigue and Other Symptoms in Systemic Sclerosis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2024 Mar;76(3):318-327. doi: 10.1002/acr.25253. Epub 2024 Jan 12.

  PMID: 37846437 DERIVED

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Susan Murphy

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and study team member who randomizes participants are blinded to participant responses at randomization. However, following assignment the blind is broken.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Medicine and Rehabilitation and Research

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: August 28, 2021
• Primary Completion: May 29, 2023
• Study Completion: May 29, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 9 months and ending 36 month after publication of primary analyses.
• Access Criteria: Proposals should be directed to sumurphy@med.umich.edu. To gain access, data requesters will need to sign a data use agreement at which time the researchers will provide access to the dataset. After 36 months, data will be deposited at the Inter-university Consortium for Political and Social Research (ICPSR) at the University of Michigan

Locations

US (1)