ClinicalTrials.Veeva

Menu

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

Case Western Reserve University logo

Case Western Reserve University

Status

Completed

Conditions

Multiple Sclerosis
Caregivers

Treatments

Behavioral: Tele-coaching
Behavioral: Website

Study type

Interventional

Funder types

Other

Identifiers

NCT04662008
MS-1610-37015 enhancement

Details and patient eligibility

About

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).

Full 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.

Enrollment

151 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

151 participants in 2 patient groups

High resource tailored intervention
Active Comparator group
Description:
Tele-coaching arm
Treatment:
Behavioral: Website
Behavioral: Tele-coaching
Low-resource web-only intervention
Active Comparator group
Description:
Website arm
Treatment:
Behavioral: Website

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems