NCT04662008

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

CLOSER_MS: Communicating With Local or Distance Caregivers Offering Support and Electronic Resources

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Caregivers

Interventions

Type	Name	Description
BEHAVIORAL	Tele-coaching	This intervention arm will receive 4 one-to-one tele-coaching sessions facilitated by an advanced practice social worker. The sessions will take place over a 6-week period and will begin with a needs assessments to allow for tailoring of the intervention sessions. The sessions will include information and support in the areas of: general MS information, strategies for caring for a loved one with MS, MS and Covid (care strategies), caring for yourself, and planning for the future. The intervention will take place using Zoom videoconferencing technology or via telephone- per subject preference. In addition, all subjects will receive access to a study-specific website. The website will have links to publicly available information including general information about MS, online information, self-care, communication, caregiving, COVID-19, future planning.
BEHAVIORAL	Website	This intervention arm will receive access to a study-specific website. The website will have links to publicly available information including: general information about MS, online information, self-care, communication, caregiving, COVID-19, future planning.

Timeline

• Start date: 2021-03-10
• Primary completion: 2022-03-07
• Completion: 2022-03-07
• First posted: 2020-12-10
• Last updated: 2022-03-31

Locations

1 site across 1 country: United States