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

Primary Purpose

Scleroderma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resilience-based, Energy Management to Enhance Wellbeing (RENEW)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Scleroderma focused on measuring Peer mentor, Web-based

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm 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.

Outcomes

Primary Outcome Measures

Feasibility as assessed by intervention participant retention
Number of participants who complete the study
Feasibility as assessed by the participation in intervention related phone calls
Number of completed peer-mentor calls

Secondary Outcome Measures

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

Full Information

First Posted
October 9, 2020
Last Updated
September 21, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04588714
Brief Title
Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention
Official Title
Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma
Keywords
Peer mentor, Web-based

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study, one arm, pre-test, post-test trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resilience-based, Energy Management to Enhance Wellbeing (RENEW)
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Resilience-based, Energy Management to Enhance Wellbeing (RENEW)
Intervention Description
The program includes unlimited website access and 10 scheduled phone calls with an assigned peer mentor.
Primary Outcome Measure Information:
Title
Feasibility as assessed by intervention participant retention
Description
Number of participants who complete the study
Time Frame
12 weeks
Title
Feasibility as assessed by the participation in intervention related phone calls
Description
Number of completed peer-mentor calls
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Feasibility as assessed by active participant involvement
Description
Number of minutes spent accessing the RENEW website/app
Time Frame
12 weeks
Title
Feasibility as assessed by the peer mentor health coach time
Time Frame
12 weeks
Title
Feasibility as assessed by the time spent in preparation for intervention phone calls
Description
Preparation time of peer mentors will be documented in minutes.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Murphy, ScD, OTR/L
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dinesh Khanna, MD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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