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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04588714

Enrollment

Registered

2020-10-19

Start date

2020-10-27

Completion date

2021-05-31

Last updated

2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scleroderma

Keywords

Peer mentor, Web-based

Brief summary

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.

Interventions

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

The program includes unlimited website access and 10 scheduled phone calls with an assigned peer mentor.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

Pilot study, one arm, pre-test, post-test trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Feasibility as assessed by intervention participant retention	12 weeks	Number of participants who complete the study
Feasibility as assessed by the participation in intervention related phone calls	12 weeks	Number of completed peer-mentor calls

Secondary

Measure	Time frame	Description
Feasibility as assessed by active participant involvement	12 weeks	Number of minutes spent accessing the RENEW website/app
Feasibility as assessed by the peer mentor health coach time	12 weeks	—
Feasibility as assessed by the time spent in preparation for intervention phone calls	12 weeks	Preparation time of peer mentors will be documented in minutes.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026