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

August 22, 2022 updated by: eSupport Health

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10018
        • eSupport Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence and completion
Time Frame: through study completion, 20-40 weeks
The primary objective is to establish feasibility, defined as acceptable rates of <1> adherence, and <2> completion.
through study completion, 20-40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: through study completion, up to 40 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment in MS (FAMS)
Time Frame: through study completion, up to 40 weeks
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
UCLA Loneliness Scale Version 3
Time Frame: through study completion, up to 40 weeks
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
Treatment adherence / healthcare utilization
Time Frame: through study completion, up to 40 weeks
A tertiary objective is to evaluate change in treatment adherence / healthcare utilization.
through study completion, up to 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

eSupport Health

Investigators

  • Principal Investigator: Victoria M Leavitt, Leavitt, eSupport Health, PBC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSO01-P001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on eSupport Health Weekly Group Sessions for PwMS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe