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

University of Michigan

Status: Completed

Conditions: Scleroderma

Treatments: Behavioral: RENEW

Study type: Interventional

Funder types: Other

Identifiers

NCT04908943

HUM00195121

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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174 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: RENEW

Waitlist

No Intervention group

Description:

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