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Recruiting NCT07011914

Care in Multiple Sclerosis (MS)

— Observational Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

CARE in MS: Childhood Adversity Research Effort in MS

Overview

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.

Primary outcome measures

  • Severity of MS [Time frame: Baseline]
Secondary outcome measures (1)
  • Age of MS Onset [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 6 centers
  • University of Alabama at Birmingham — Birmingham
  • University of California, San Francisco — San Francisco
  • University of Colorado Denver — Aurora
  • Massachusetts General Hospital — Boston
  • Cleveland Clinic — Cleveland
  • Baylor College of Medicine — Houston

Identifiers

NCT: NCT07011914 · 24-00939 · 1R01NS139999

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗