Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415942
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-13
Brief Title:
Assessing the Maternal Outcome Monitoring Systems
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOMS
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 patients 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 MOMSMAMA for improving knowledge and patient activation among postpartum patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R00MD015781-04 | NIH | None | httpsreporternihgovquickSearch5R00MD015781-04 |