Clinical trial NCT04662008: Offering Support and Electronic Resources for Care Partners of Those With Multiple Sclerosis
Official title: CLOSER_MS: Communicating With Local or Distance Caregivers Offering Support and Electronic Resources
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Caregivers
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: anxiety, depression, and stress (DASS-42)
timeFrame: Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks
Secondary outcomes:
measure: COVID specific anxiety (CAS scale)
timeFrame: Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
References:
citation: 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.