Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester

Pregnancy Related Clinical Trial

— Her Health  

Official title:

Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06298214
• Other study ID #: RP-23-019
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: February 2024
• Source: Woman's
• Contact: Briasha Jones, MPH
• Phone: 225-428-7464
• Email: briasha.jones[@]womans.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby.

The main question[s] the study aims to answer are:

• Can the Her Health program increase access to healthcare in the first year postpartum?

• Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system?

Participants will complete one research visit in which they will be enrolled and told which group they will be in- "Her Health Program" group or "Usual Care" group. If they are placed in the "Her Health Program" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum.

Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• At least 16 years old at the time of consent.

• Gave birth within 7 days before randomization

• Medicaid enrolled

• Address of residence within a disadvantaged area (ADI>5).

• Clearly understands the study procedures and visit schedule, alternative treatments, and risks involved with the study, and voluntarily agrees to participate by giving verbal and written informed consent

Exclusion Criteria:

• Use of private health insurance exclusively

• Does not speak English.

• Plans to move out of state during the study time period

• Unwilling to provide permission to link study records, medical records, and Medicaid and Vital Records Database records.

• Unwilling to provide informed consent

• Unwilling to be randomized.

Related Conditions & MeSH terms

• Postpartum
• Pregnancy Related

Intervention

Behavioral:
• Her Health Program
Addition of a community health worker navigator to assist subject in navigating their health in the first year postpartum.

Locations

Country	Name	City	State
United States	Woman's Hospital	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth F Sutton, PhD	Donaghue Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum visit attendance	Visit attended between 6-12 weeks of delivery (yes/no)	12 weeks postpartum
Secondary	Medical trust	Group-Based Medical Mistrust Scale; scores range from 12-60 with higher scores indicating more mistrust	12 months postpartum
Secondary	Health literacy	Rapid Estimate of Adult Literacy in Medicine (REALM); scores 0-66; higher score indicates high literacy	12 months postpartum
Secondary	Self-efficacy	PROMIS General Self-Efficacy; scores range 5-50; higher score indicates higher self-efficacy	12 months postpartum
Secondary	Healthcare costs	total cost of healthcare from Medicaid Claims Database within the first 12 months after delivery	12 months postpartum