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

NCT04588714 | Completed

• 1 other identifier: HUM00186877
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma

Keywords

Peer mentor; Web-based

Outcome Measures

Primary Outcomes (2)

• Feasibility as assessed by intervention participant retention

  Number of participants who complete the study

  12 weeks

• Feasibility as assessed by the participation in intervention related phone calls

  Number of completed peer-mentor calls

  12 weeks

Secondary Outcomes (3)

• Feasibility as assessed by active participant involvement

  12 weeks

• 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

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Susan Murphy, ScD, OTR/L

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Dinesh Khanna, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Medicine and Rehabilitation and Research Associate Professor, Institute of Gerontology, Medical School

Model Details: Pilot study, one arm, pre-test, post-test trial

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: October 27, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)