Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester
Part of paid clinical trials in Baton Rouge, Louisiana.
- Sponsor
- Elizabeth F Sutton, PhD
- Study ID
- NCT06298214
- Status
- Enrolling By Invitation
Conditions
- Postpartum
- Pregnancy Related
Eligibility Criteria
- Sex
- FEMALE
- Age
- 16 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Her Health Program — BEHAVIORALAddition of a community health worker navigator to assist subject in navigating their health in the first year postpartum.
Study Details
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.
Key Dates
- Start date
- May 29, 2024
- Status verified
- Mar 2025
- Primary completion
- Jan 1, 2026
- Completion
- Jun 1, 2026
Study Design
- Enrollment
- 500 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- No Intervention: Usual CareSubjects will see doctors as normal during first year postpartum with no assistance.
- Experimental: Her Health ProgramHer 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.
Primary Outcome Measure
Postpartum visit attendance [ Time Frame: 12 weeks postpartum ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Woman's Hospital | Baton Rouge | Louisiana | 70817 | - |
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