Self-Guided Resilience-Building Energy Management to Enhance Well-being (RENEW) Intervention for People With Systemic Sclerosis (SSc)

University of Michigan43 enrolled

Overview

The goal of this clinical trial is to gather information on the RENEW app used by people with scleroderma. Specifically, the researchers want to learn more about RENEW by collecting information about the rates of recruitment, retention of study participants information about study completion, and time spent accessing the app content.

RENEW is Institutional Review Board approved as a non-significant risk device but it not subject to 510(k) and therefore not regulated by the FDA.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Systemic Sclerosis

Interventions

RENEWDEVICE

The RENEW program is 12-week program where participants are asked to access the app and set and track weekly healthy goals.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a diagnosis of systemic sclerosis including: diffuse cutaneous SSc, limited cutaneous SSc, overlap, or SINE * Have access to a reliable, internet-connected device (e.g. smartphone or 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 conditions1 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 * Previous experience with RENEW app or past participant of RENEW

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Feasibility based on study recruitment rate

Number of participants enrolled (over 3 months) divided by the number of individuals who were eligible to participate

Time frame: 12 weeks

Feasibility based on study retention

Number of participants who complete the study

Time frame: 12 weeks

Secondary Outcomes

RENEW participation - website

Reported as the number of minutes spent accessing the RENEW app

Time frame: 12 weeks

Acceptability

Assessed using the 12-week feedback questionnaire

Time frame: 12 weeks

Data from ClinicalTrials.gov

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