Care in Multiple Sclerosis (MS)

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

RECRUITING

Total Enrollment

386 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-23

Study Completion Date

2029-06-30

Brief Summary

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This study is structured around three main aims.

In Aim 1, investigators will conduct community-based participatory research (CBPR) to develop culturally tailored methods to assess childhood adversity in multiple sclerosis (MS).

Aim 2 will investigate the impact of childhood adversity on MS outcomes among individuals with relapsing-remitting MS (RRMS), among whom 70% belong to a group historically under-represented in MS research: Black, Hispanic, or poverty-impacted. Aim 2 procedures involve two visits that include a research blood draw and an MRI scan.

In Aim 3, investigators will conduct interviews and surveys to explore environmental and social factors affecting quality of life for minority MS patients.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aim 1: Adults with RRMS - Focus Groups

Aim 1 will involve 2-3 focus groups, each with 8-12 participants per group. The focus group sessions will occur only one time and will take around 90-120 minutes. Aim 1 will enroll individuals with RRMS who self-identify as a Black, Hispanic, or poverty-impacted.

No interventions assigned to this group

Aim 2: Young Adults with MS - MRI Scan

Participants enrolled in Aim 2 will complete a baseline visit and research MRI occurring around and in concurrence with their routine/standard of care visit. The study visit is estimated to take around 1 to 1.5 hours. The MRI scan is estimated to take 30 minutes. The research team will maintain contact with study participants at least annually (up to 4 years).

Aim 2 will enroll 330 young adults, of whom 165 have pediatric-onset RRMS and 165 have adult-onset RRMS. Further, 70% of participants in Aim 2 must self-identify as persons with MS who are either Black, Hispanic, or poverty-impacted.

No interventions assigned to this group

Aim 3: Young Adults with MS - Interviews

Aim 3 will involve one-time interviews estimated to take 30 to 45 minutes to complete. Aim 3 will enroll 20 participants who have completed at least 80% of study data in Aim 2; further, 70% of participants enrolled Aim 3 participants must self-identify as Black, Hispanic, or meet criteria for poverty impacted.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Aim 1 -

* aged ≥18-29 years
* diagnosis of RRMS (Fulfill international criteria for relapsing remitting (RRMS))
* 70% self-identifying as a Black, Hispanic, or poverty-impacted (up to 138% of the federal poverty level) individual,and
* fluent in English or Spanish.

Aim 2 -

* aged ≥18-29 years
* diagnosis of RRMS (Fulfill international criteria for relapsing remitting (RRMS))
* 70% self-identifying as a Black, Hispanic, or poverty impacted, and
* fluent reading in English or Spanish
* Pediatric onset MS (MS onset before age 18 and age at time of enrollment is 18-25) OR adult-onset MS (MS onset at age 18 or older and age at time of enrollment is 19-29)
* Disease duration below 8 years

Aim 3 -

Aim 3 will enroll the first 20 participants from Aim 2 who meet the following criteria:

* completed at least 80% of study data in the cross-sectional study/Aim 2.
* a total of 70% must self-identify as Black, Hispanic, or meet criteria for poverty impacted.
* interviews will be evenly split between participants with high (top quartile) and low (bottom quartile) of PROMIS-10 scores.

Exclusion Criteria

* Primary or Secondary Progressive MS
* Inability to consent.
* MS relapse within 30 days prior to study entry
* Other major neurologic or psychiatric illness

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No