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

NCT ID: NCT04588714

Last Updated: 2022-09-23

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

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-27

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Scleroderma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot study, one arm, pre-test, post-test trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Interventions

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

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Susan Murphy

Associate Professor of Physical Medicine and Rehabilitation and Research Associate Professor, Institute of Gerontology, Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Murphy, ScD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Dinesh Khanna, MD, MS

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

Other Identifiers

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HUM00186877

Identifier Type: -

Identifier Source: org_study_id

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