Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention

University of Michigan

Status: Completed

Conditions: Scleroderma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04588714

HUM00186877

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

21 participants in 1 patient group

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

Experimental group

Description:

RENEW is a 12-week program in which participants are paired with a peer mentor who serves as their health coach throughout the intervention period. The website serves as the program "workbook" to help promote skill practice and attainment in areas like goal setting, pacing, relaxation, etc.

Treatment:

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