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

NCT ID: NCT04908943

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-28

Study Completion Date

2023-05-29

Brief Summary

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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.

Detailed Description

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Conditions

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Scleroderma

Keywords

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Systemic Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators
Participants and study team member who randomizes participants are blinded to participant responses at randomization. However, following assignment the blind is broken.

Study Groups

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

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.

Group Type EXPERIMENTAL

RENEW

Intervention Type 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.

Waitlist

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RENEW

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rheumatology Research Foundation

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Susan Murphy

Professor of Physical Medicine and Rehabilitation and Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Murphy

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38910596 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38622109 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38618141 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37846437 (View on PubMed)

Other Identifiers

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HUM00195121

Identifier Type: -

Identifier Source: org_study_id