## Protocol Section
### Identification Module
**NCT ID:** NCT06415942

**Acronym:** MOMS

**Brief Title:** 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

#### Organization Study ID Info
**ID:** AAAU9647
#### Organization
**Class:** OTHER
**Full Name:** Columbia University
#### Secondary ID Infos
**ID:** 5R00MD015781-04
**Link:** https://reporter.nih.gov/quickSearch/5R00MD015781-04
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-01-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute on Minority Health and Health Disparities (NIMHD)

#### Lead Sponsor

**Class:** OTHER

**Name:** Columbia University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Maternal Death

- Maternal Complication of Pregnancy

**Keywords:**

- pregnancy related death

- patient reported outcomes

- mHealth

- patient activation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants in this condition will receive the MOMS symptom monitoring and decision support intervention. This is a single arm trial.

**Intervention Names:**

- Other: Maternal Outcome Monitoring and Support system

**Label:** MOMS intervention

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MOMS intervention

**Description:** The Maternal Outcome Monitoring and Support system is a mobile health application that allows participants to choose symptoms they may be having that are warning signs of pregnancy related death. They then receive decision support about when they should seek medical care (call their provider or go to an emergency room).

**Name:** Maternal Outcome Monitoring and Support system

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Change in patient activation measured using the validated Patient Activation Measure (PAM)

**Measure:** Patient activation

**Time Frame:** Baseline to 6 weeks postpartum

#### Secondary Outcomes

**Description:** Change in knowledge of warning signs for pregnancy related death

**Measure:** Knowledge of pregnancy related death warning signs

**Time Frame:** Baseline to 6 weeks postpartum

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nb3115@cumc.columbia.edu

**Name:** Natalie Benda

**Phone:** 917-426-3069

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** nb3115@cumc.columbia.edu

- **Name:** Natalie Benda

- **Role:** CONTACT

***Contact 2:***

- **Name:** Natalie Benda, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** NewYork-Presbyterian Columbia University Irving Medical Center

**State:** New York

**Zip:** 10032

**Location 2:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** ncb4001@med.cornell.edu

- **Name:** Natalie Benda

- **Role:** CONTACT

***Contact 2:***

- **Email:** rbk9001@med.cornell.edu

- **Name:** Robin Kalish

- **Role:** CONTACT

**Country:** United States

**Facility:** NewYork-Prebyterian/Weill Cornell Medical Center

**State:** New York

**Zip:** 10065

### IPD Sharing Statement Module

**Description:** Data will be shared in the aggregate. There is no plan to make IDP available to other researchers.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003643

- Term: Death

- ID: D000010335

- Term: Pathologic Processes

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000063129

- Term: Parental Death

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M14127

- Name: Pregnancy Complications

- Relevance: HIGH

- As Found: Complication of Pregnancy

- ID: M6845

- Name: Death

- Relevance: LOW

- As Found: Unknown

- ID: M30058

- Name: Maternal Death

- Relevance: HIGH

- As Found: Maternal Death

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M30057

- Name: Parental Death

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000063130

- Term: Maternal Death

- ID: D000011248

- Term: Pregnancy Complications

### Misc Info Module

- Version Holder: 2024-05-31
