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

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Caregivers
• Intervention / Treatment: Behavioral: Tele-coaching; Behavioral: Website

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 Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44124
      • Case Western Reserve University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High resource tailored intervention; Tele-coaching arm	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.
Active Comparator: Low-resource web-only intervention; Website arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety, depression, and stress (DASS-42)	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.	Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID specific anxiety (CAS scale)	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.	Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks

Collaborators and Investigators

• Sponsor: Case Western Reserve University

Publications and helpful links

General Publications

• Douglas SL, Plow M, Packer T, Lipson AR, Lehman MJ. Psychoeducational Interventions for Caregivers of Persons With Multiple Sclerosis: Protocol for a Randomized Trial. JMIR Res Protoc. 2021 Aug 26;10(8):e30617. doi: 10.2196/30617.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): March 7, 2022
• Study Completion (Actual): March 7, 2022

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: MS-1610-37015 enhancement

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No