RECRUITING

MOMs Chat and Care Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care for high-risk Black and Hispanic/Latina birthing people and reduce risk for severe maternal morbidity (SMM). Eligible Black and Hispanic/Latina birthing people (n = 674) will be recruited and randomized to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). The two study arms will be compared on incidence of SMM at labor and delivery (Aim 1), incidence rate of SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and initiation of treatment (Aim 2), change in perceived social support domains (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will also be used to examine facilitators and barriers to implementation (Aim 5). Findings from this study will help to determine how to feasibly implement an effective and sustainable integrated care approach to address SMM disparities.

Official Title

Maternal OutcoMes (MOMs) Program: Testing Integrated Maternal Care Model Approaches to Reduce Disparities in Severe Maternal Morbidity

Quick Facts

Study Start:2024-05-28
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06335381

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 or older,
  2. * Self-identify as Black/African American or Hispanic/Latina (includes Black + another race; Black or Afro Hispanic/Latina; or Hispanic/Latina),
  3. * Pregnant, less than 17 weeks gestational age,
  4. * OB-CMI risk score ≥ 2 and/or history or preeclampsia,
  5. * English or Spanish as primary language, and
  6. * Receive care at Northwell Health Physician Partners obstetrics practice site.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Stephanie L Fitzpatrick, PhD
CONTACT
646-766-7167
sfitzpatrick1@northwell.edu
Patti Ephraim, MPH
CONTACT
410-493-9186
pephraim@northwell.edu

Principal Investigator

Stephanie L Fitzpatrick, PhD
PRINCIPAL_INVESTIGATOR
Northwell Health

Study Locations (Sites)

Northwell Health
Manhasset, New York, 11030
United States

Collaborators and Investigators

Sponsor: Northwell Health

  • Stephanie L Fitzpatrick, PhD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-28
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2024-05-28
Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

  • Maternal health
  • Severe maternal morbidity

Additional Relevant MeSH Terms

  • Severe Maternal Morbidity