Clinical trial NCT06415942: Assessing the Maternal Outcome Monitoring Systems
Official title: Single Arm Clinical Trial of a Novel Smartphone-based Somatic and Psychological Symptom Monitoring and Decision Support Tool for African American and Spanish Speaking Patients in the Near Postpartum Period
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Death
Maternal Complication of Pregnancy
Keywords: pregnancy related death
patient reported outcomes
mHealth
patient activation
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-05-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Pregnancy-related death is a growing public health issues, which are of particular concern to minority groups, including African-Americans and Spanish-speaking Latinas. Our proposal aims to improve a patient's ability to detect warning signs of pregnancy related death and seek medical care.

Detailed description: Pregnancy-related death (PRD) rates have risen 120-200% in the United States in the past two decades, and experts estimate that 40-60% of these cases are preventable. Improvement initiatives are predominantly hospital-based and rely on perinatal people recognizing their own symptoms and seeking care without ample support or education. We hypothesize that we can improve patients' self-efficacy and decision-making about when to seek care by helping them to self-monitor symptoms and by providing decision support. We propose to develop a mHealth-based, patient-reported outcome (PRO) and decision-support system to help mothers determine when to seek care for warning signs of PRD. Our project focuses on diverse populations facing postpartum disparities, particularly African- American and Spanish-speaking Latina women. This protocol involves a single-arm pilot trial assessing the feasibility and preliminary effectiveness of MOMS/MAMA for improving knowledge and patient activation among postpartum patients.

Eligibility criteria: Inclusion Criteria:

* Greater than 28 weeks pregnant
* Receiving healthcare in the United States
* Age 18 years or older
* \[Identify as Black or African American race AND able to speak and read English, AND preferred language of English\] OR \[Identify as Hispanic/Latino Ethnicity AND Spanish able to speak and read Spanish AND preferred language of Spanish\]
* Planned delivery at the following NewYork-Presbyterian hospitals: Children's Hospital of New York, Allen Hospital, Weill Cornell Medical Center, Lower Manhattan Hospital

Exclusion Criteria:

* Severe cognitive impairment
* Major psychiatric illness
* Concomitant terminal illness that would preclude participation.

Primary outcomes:
measure: Patient activation
timeFrame: Baseline to 6 weeks postpartum
Secondary outcomes:
measure: Knowledge of pregnancy related death warning signs
timeFrame: Baseline to 6 weeks postpartum
Other outcomes:
Locations:
city: New York
country: United States
facility: NewYork-Presbyterian Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: NewYork-Prebyterian/Weill Cornell Medical Center
state: New York
Study officials:
References: