Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Donaghue Medical Research Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Subjects will see doctors as normal during first year postpartum with no assistance. | |
| Her Health Program | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Her Health Program | Behavioral | Addition of a community health worker navigator to assist subject in navigating their health in the first year postpartum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postpartum visit attendance | Visit attended between 6-12 weeks of delivery (yes/no) | 12 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Medical trust | Group-Based Medical Mistrust Scale; scores range from 12-60 with higher scores indicating more mistrust | 12 months postpartum |
| Health literacy | Rapid Estimate of Adult Literacy in Medicine (REALM); scores 0-66; higher score indicates high literacy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Sutton, PhD | Woman's Hospital, Louisiana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woman's Hospital | Baton Rouge | Louisiana | 70817 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2023 | Feb 2, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 6, 2023 | Feb 2, 2024 | ICF_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months postpartum |
| Self-efficacy | PROMIS General Self-Efficacy; scores range 5-50; higher score indicates higher self-efficacy | 12 months postpartum |
| Healthcare costs | total cost of healthcare from Medicaid Claims Database within the first 12 months after delivery | 12 months postpartum |