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OpenTrials
Enrolling by Invitation

NCT Number: NCT06298214

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

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.

Enrolling by Invitation

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Key information

Conditions

Postpartum Pregnancy Related

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Woman's Hospital

Baton Rouge, Louisiana, 70817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Her Health Program

Behavioral

Addition of a community health worker navigator to assist subject in navigating their health in the first year postpartum.

Primary outcomes

  1. Postpartum visit attendance

    Time frame: 12 weeks postpartum

    Visit attended between 6-12 weeks of delivery (yes/no)

Secondary outcomes

  1. Medical trust

    Time frame: 12 months postpartum

    Group-Based Medical Mistrust Scale; scores range from 12-60 with higher scores indicating more mistrust

  2. Health literacy

    Time frame: 12 months postpartum

    Rapid Estimate of Adult Literacy in Medicine (REALM); scores 0-66; higher score indicates high literacy

  3. Self-efficacy

    Time frame: 12 months postpartum

    PROMIS General Self-Efficacy; scores range 5-50; higher score indicates higher self-efficacy

  4. Healthcare costs

    Time frame: 12 months postpartum

    total cost of healthcare from Medicaid Claims Database within the first 12 months after delivery

Sponsors and collaborators

Lead sponsor

Elizabeth F Sutton, PhD

Other

Collaborators

  • Donaghue Medical Research Foundation

Registry information

Acronym: Her Health

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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