CONNECT Trial of eSupport Online Health-coach Moderated Support Groups for Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— CONNECT  

Official title:

Clinical Trial of a Telehealth Group-Based Intervention to Improve Mood in Underrepresented Individuals With Multiple Sclerosis: The Connect Trial (CONNECT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04943887
• Other study ID #: MSO01-P001
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2022
• Source: eSupport Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Within-subject waitlist-control group design trial of eSupport health-coach moderated online support group participation to address mental health needs in persons with multiple sclerosis (PwMS) from historically underrepresented groups (i.e., Black and Latinx patients).

Description:

The purpose of this research is to see how well a new online eSupport Health Weekly Group Sessions program addresses the needs and improves the mood of adults with MS. This study is focusing on improving the online eSupport Weekly Group Session program for people with MS while assessing the impact of the program, particularly for Black and Latinx individuals as clinical research has often not included their experience. The entire study is done remotely by computer, tablet, or smartphone with a web camera and with a stable internet connection. Subjects will be enrolled into closed, private, health-coach facilitated online support groups called eSupport Health Weekly Group Sessions. These sessions are hosted on eSupport Health's proprietary Zoom-based secure HIPAA-compliant telehealth platform. Each group is expected to have 10 participants and will meet weekly for 12 weeks. A licensed therapist ("Study Coach") leads the group sessions. The company's Mutual Respect & Trust (MRT)-based coaching method is utilized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provision of signed and dated informed consent form (ICF)
• Able to speak, read and understand English
• Reside in the U.S.
• Willingness to enroll as a member in eSupport Health
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Willingness to adhere to the schedule of weekly online meetings with a minimum of 50% attendance (i.e., 6 of 12 meetings)
• Males and females; Age 18+
• Self-reported diagnosis of multiple sclerosis including the date of the diagnosis (month and year) and the name of the diagnosing physician
• Access to necessary resources for participating in a technology-based intervention (i.e., computer or tablet with a web camera and with a stable internet connection in a private setting) and demonstrated basic ability to use a computer by completing the electronic ICF completion process and meeting with the Study Coach via Zoom Telehealth secured platform at the Enrollment Session.
• Provide identification to verify name, date of birth, and address.

Exclusion Criteria:

1. Current participation in another treatment or intervention study

2. Presence of a condition(s) or diagnosis, either physical or psychological that precludes participation such as significant brain injury and developmental disability

3. Current suicidal intent

4. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• eSupport Health Weekly Group Sessions for PwMS
A formal semi-structured program of psychoeducational support delivered in an online weekly small group format by health coaches (licensed therapists) who specialize in MS.

Locations

Country	Name	City	State
United States	eSupport Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
eSupport Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional Assessment in MS (FAMS)	A tertiary objective is to determine efficacy: whether participation in 12-weeks of eSupport Health online groups results in improved quality of life.	through study completion, up to 40 weeks
Other	UCLA Loneliness Scale Version 3	A tertiary objective is to determine efficacy: whether participation in 12-weeks of eSupport Health online groups results in decreased loneliness.	through study completion, up to 40 weeks
Other	Treatment adherence / healthcare utilization	A tertiary objective is to evaluate change in treatment adherence / healthcare utilization.	through study completion, up to 40 weeks
Primary	Adherence and completion	The primary objective is to establish feasibility, defined as acceptable rates of <1> adherence, and <2> completion.	through study completion, 20-40 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)	The primary efficacy outcome is to determine whether participation in 12-weeks of eSupport Health online groups results in decreased anxiety or depression.	through study completion, up to 40 weeks