Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester
NCT ID: NCT06298214
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
500 participants
INTERVENTIONAL
2024-05-29
2026-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Usual Care
Subjects will see doctors as normal during first year postpartum with no assistance.
No interventions assigned to this group
Her Health Program
Her Health is a patient navigation intervention delivered by community health workers across the first postpartum year. Her Health has two interspersed components: Navigation and Education. Her Health Navigation is delivered through weekly and monthly check-ins between participant and navigator. Her Health navigators will deliver historically informed and culturally competent education designed to promote self-efficacy and self-advocacy within the healthcare system.
Her Health Program
Addition of a community health worker navigator to assist subject in navigating their health in the first year postpartum.
Interventions
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Her Health Program
Addition of a community health worker navigator to assist subject in navigating their health in the first year postpartum.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
16 Years
FEMALE
No
Sponsors
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Donaghue Medical Research Foundation
OTHER
Elizabeth F Sutton, PhD
OTHER
Responsible Party
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Elizabeth F Sutton, PhD
Director of Scientific Research
Principal Investigators
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Elizabeth Sutton, PhD
Role: PRINCIPAL_INVESTIGATOR
Woman's Hospital, Louisiana
Locations
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Woman's Hospital
Baton Rouge, Louisiana, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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RP-23-019
Identifier Type: -
Identifier Source: org_study_id
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