Back to resultsCONNECT Trial of eSupport Online Health-coach Moderated Support Groups for Multiple Sclerosis (CONNECT)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eSupport Health Weekly Group Sessions for PwMS
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis focused on measuring Online Support Group
Eligibility Criteria
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:
- Current participation in another treatment or intervention study
- Presence of a condition(s) or diagnosis, either physical or psychological that precludes participation such as significant brain injury and developmental disability
- Current suicidal intent
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Sites / Locations
- eSupport Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PwMS eSupport Groups
Arm Description
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.
Outcomes
Primary Outcome Measures
Adherence and completion
The primary objective is to establish feasibility, defined as acceptable rates of <1> adherence, and <2> completion.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04943887
Brief Title
CONNECT Trial of eSupport Online Health-coach Moderated Support Groups for Multiple Sclerosis
Acronym
CONNECT
Official Title
Clinical Trial of a Telehealth Group-Based Intervention to Improve Mood in Underrepresented Individuals With Multiple Sclerosis: The Connect Trial (CONNECT)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
eSupport Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Online Support Group
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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].
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PwMS eSupport Groups
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
eSupport Health Weekly Group Sessions for PwMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence and completion
Description
The primary objective is to establish feasibility, defined as acceptable rates of <1> adherence, and <2> completion.
Time Frame
through study completion, 20-40 weeks
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
The primary efficacy outcome is to determine whether participation in 12-weeks of eSupport Health online groups results in decreased anxiety or depression.
Time Frame
through study completion, up to 40 weeks
Other Pre-specified Outcome Measures:
Title
Functional Assessment in MS (FAMS)
Description
A tertiary objective is to determine efficacy: whether participation in 12-weeks of eSupport Health online groups results in improved quality of life.
Time Frame
through study completion, up to 40 weeks
Title
UCLA Loneliness Scale Version 3
Description
A tertiary objective is to determine efficacy: whether participation in 12-weeks of eSupport Health online groups results in decreased loneliness.
Time Frame
through study completion, up to 40 weeks
Title
Treatment adherence / healthcare utilization
Description
A tertiary objective is to evaluate change in treatment adherence / healthcare utilization.
Time Frame
through study completion, up to 40 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Current participation in another treatment or intervention study
Presence of a condition(s) or diagnosis, either physical or psychological that precludes participation such as significant brain injury and developmental disability
Current suicidal intent
Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria M Leavitt, Leavitt
Organizational Affiliation
eSupport Health, PBC
Official's Role
Principal Investigator
Facility Information:
Facility Name
eSupport Health
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
CONNECT Trial of eSupport Online Health-coach Moderated Support Groups for Multiple Sclerosis
We'll reach out to this number within 24 hrs