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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06298214
Acronym
Her Health
Enrollment
500
Registered
2024-03-07
Start date
2024-05-29
Completion date
2026-06-01
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum, Pregnancy Related

Brief 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.

Interventions

BEHAVIORALHer Health Program

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

Sponsors

Donaghue Medical Research Foundation
CollaboratorOTHER
Elizabeth F Sutton, PhD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postpartum visit attendance12 weeks postpartumVisit attended between 6-12 weeks of delivery (yes/no)

Secondary

MeasureTime frameDescription
Medical trust12 months postpartumGroup-Based Medical Mistrust Scale; scores range from 12-60 with higher scores indicating more mistrust
Health literacy12 months postpartumRapid Estimate of Adult Literacy in Medicine (REALM); scores 0-66; higher score indicates high literacy
Self-efficacy12 months postpartumPROMIS General Self-Efficacy; scores range 5-50; higher score indicates higher self-efficacy
Healthcare costs12 months postpartumtotal cost of healthcare from Medicaid Claims Database within the first 12 months after delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026