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

NCT ID: NCT04943887

Last Updated: 2022-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-06-01

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each participant will serve as his/her own control; after a 12-week waitlist control period, each participant will complete a 12-week treatment period \[note that the very first group of enrolled participants (N \~10) will not have a waitlist period, but will instead enter directly into the 12-week treatment period\].
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PwMS eSupport Groups

12-weeks active treatment of eSupport Health's Weekly Group Sessions, a formal semi-structured program of psychoeducational support delivered in a small group format by licensed therapists who specialize in MS. The active treatment period will follow a 12-week waitlist period that will be used to enable a within-subject control design. Note that the very first group enrolled (N\~10) will not have a 12-week waitlist period but will instead enter directly into the 12-week treatment.

Group Type EXPERIMENTAL

eSupport Health Weekly Group Sessions for PwMS

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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eSupport Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victoria M Leavitt, Leavitt

Role: PRINCIPAL_INVESTIGATOR

eSupport Health, PBC

Locations

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eSupport Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MSO01-P001

Identifier Type: -

Identifier Source: org_study_id

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