CARE in MS: Childhood Adversity Research Effort in MS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Severity of MS
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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 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
- •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.
排除标准
- •Primary or Secondary Progressive MS
- •Inability to consent.
- •MS relapse within 30 days prior to study entry
- •Other major neurologic or psychiatric illness
研究组 & 干预措施
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.
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.
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.
结局指标
主要结局
Severity of MS
时间窗: Baseline
Severity of MS will be measured by MRI FLAIR lesion volume among Aim 2 participants.
次要结局
- Age of MS Onset(Baseline)