Offering Support and Electronic Resources for Care Partners of Those With Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Caregivers
• Interventions: Behavioral: Tele-coaching; Behavioral: Website

• Registration Number: NCT04662008
• Lead Sponsor: Case Western Reserve University

Brief Summary

This study is an enhancement of the Fatigue Management Programs for People with MS study (NCT03550170). The purpose of this randomized clinical trial is to test the effectiveness of two interventions delivered remotely to support unpaid caregivers (UC) of people with multiple sclerosis (MS). We hypothesize that a high resource intervention will be significantly better than a lower resource intervention in terms of the primary outcome (UC anxiety, depression, and stress) and secondary outcome (COVID specific anxiety).

Detailed Description

UCs are often caring for persons with chronic disabling conditions, who are at higher risk for severe COVID-19 illness. This presents incredibly stressful situations for UCs, which can result in depression, anxiety, and worse health outcomes both for them and their care recipients. Until a vaccine becomes available, these demands will force UCs to provide more support, whether in-person or remotely, for persons with MS. The aim of this study is to compare 2 modes of supporting UCs of people with MS. We will compare the effectiveness of a high resource highly tailored intervention that includes tele-coaching intervention (delivered via videoconference or phone) + web site information to a low-resource web-site only intervention. Our primary outcomes are UC anxiety, depression, and stress (DASS-42 scale) and a secondary outcome is COVID specific anxiety (CAS scale). These 2 interventions were selected because they will inform administrators and clinicians on whether a resource-intensive or a low-resource intervention is needed to yield meaningful outcomes. The comparison will also help UC decide how they should spend their limited time. These interventions are relevant to UCs of people with MS because of their need for tailored information provided in flexible ways to promote learning and support.

Study Timeline

• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-10
• Study Start: 2021-03-10
• Status Verified: 2022-03
• Primary Completion: 2022-03-07
• Study Completion: 2022-03-07
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

1. An adult family member or friend (18 years of age or older) of a person with MS
2. Self-identified as an unpaid caregiver for person with MS
3. Access to internet
4. Capable of providing informed consent in English

Exclusion Criteria

1. Under age 18
2. Cannot speak English
3. Unable to provide consent
4. No access to the internet

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High resource tailored intervention	Website	Tele-coaching arm
Low-resource web-only intervention	Website	Website arm
High resource tailored intervention	Tele-coaching	Tele-coaching arm

Primary Outcome Measures

Name	Time	Method
anxiety, depression, and stress (DASS-42)	Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks	Change from baseline in anxiety, depression, and stress levels. Each of the three DASS scales contains 14 items. Using a 4-point Likert scale, scores range from 0- 42 for each scale. Higher scores indicate more depression, anxiety, and stress.

Secondary Outcome Measures

Name	Time	Method
COVID specific anxiety (CAS scale)	Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks	Change from baseline in COVID specific anxiety. Using a 5-point scale, from 0 (not at all) to 4 (nearly every day), total score ranges from 0-20 while individual items range from 0-4. Higher scores indicate higher anxiety.

Trial Locations

Locations (1)

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States