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

NCT04662008 | Completed

• 1 other identifier: MS-1610-37015 enhancement
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis; Caregivers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• COVID specific anxiety (CAS scale)

  Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks

Study Arms (2)

High resource tailored intervention

ACTIVE COMPARATOR

Tele-coaching arm

Behavioral: Tele-coaching; Behavioral: Website

Low-resource web-only intervention

ACTIVE COMPARATOR

Website arm

Behavioral: Website

Interventions

Tele-coaching BEHAVIORAL

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.

High resource tailored intervention

Website BEHAVIORAL

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.

High resource tailored intervention; Low-resource web-only intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Under age 18
• Cannot speak English
• Unable to provide consent
• No access to the internet

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44124, United States

Location

Related Publications (1)

• 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.

  PMID: 34435971 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 10, 2020
• Study Start: March 10, 2021
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)