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

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT04588714
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Scleroderma	Behavioral: Resilience-based, Energy Management to Enhance Wellbeing (RENEW)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pilot study, one arm, pre-test, post-test trialPilot study, one arm, pre-test, post-test trial
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention
• Actual Study Start Date: Oct 27, 2020
• Actual Primary Completion Date: May 31, 2021
• Actual Study Completion Date: May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Resilience-based, Energy Management to Enhance Wellbeing (RENEW); The program includes unlimited website access and 10 scheduled phone calls with an assigned peer mentor.

Outcome Measures

Primary Outcome Measures

1. Feasibility as assessed by intervention participant retention [12 weeks]

   Number of participants who complete the study

2. Feasibility as assessed by the participation in intervention related phone calls [12 weeks]

   Number of completed peer-mentor calls

Secondary Outcome Measures

1. Feasibility as assessed by active participant involvement [12 weeks]

   Number of minutes spent accessing the RENEW website/app

2. Feasibility as assessed by the peer mentor health coach time [12 weeks]

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Susan Murphy, ScD, OTR/L, University of Michigan
• Principal Investigator: Dinesh Khanna, MD, MS, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Susan Murphy, Associate Professor of Physical Medicine and Rehabilitation and Research Associate Professor, Institute of Gerontology, Medical School, University of Michigan
• ClinicalTrials.gov Identifier: NCT04588714
• Other Study ID Numbers: HUM00186877
• First Posted: Oct 19, 2020
• Last Update Posted: Oct 11, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Susan Murphy, Associate Professor of Physical Medicine and Rehabilitation and Research Associate Professor, Institute of Gerontology, Medical School, University of Michigan: Peer mentor; Web-based
• Additional relevant MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse

Study Results

No Results Posted as of Oct 11, 2021