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

NCT04943887 | Completed

• 1 other identifier: MSO01-P001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Keywords

Online Support Group

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hospital Anxiety and Depression Scale (HADS)

  through study completion, up to 40 weeks

Other Outcomes (3)

• Functional Assessment in MS (FAMS)

  through study completion, up to 40 weeks

• UCLA Loneliness Scale Version 3

  through study completion, up to 40 weeks

• Treatment adherence / healthcare utilization

  through study completion, up to 40 weeks

Study Arms (1)

PwMS eSupport Groups

EXPERIMENTAL

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

Interventions

eSupport Health Weekly Group Sessions for PwMS 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.

PwMS eSupport Groups

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• eSupport Health: lead

Study Sites (1)

eSupport Health

New York, New York, 10018, United States

Location

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 Officials

• Victoria M Leavitt, Leavitt

  eSupport Health, PBC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 \[note that the very first group of enrolled participants (N \~10) will not have a waitlist period, but will instead enter directly into the 12-week treatment period\].

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 29, 2021
• Study Start: August 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)