PostpartumHer HealthNCT06298214
Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester
A study testing Her Health Program in people with Postpartum and Pregnancy Related, run by Elizabeth F Sutton, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Postpartum, Pregnancy Related
- What is being tested?
- Her Health Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
- 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.
- Conditions
- Postpartum, Pregnancy Related
- Being tested
- Her Health Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Her Health ProgramBehavioural
Addition of a community health worker navigator to assist subject in navigating their health in the first year postpartum.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Her Health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum visit attendance
Visit attended between 6-12 weeks of delivery (yes/no)
Measured: 12 weeks postpartum
Secondary outcomes (4)
Medical trust
Group-Based Medical Mistrust Scale; scores range from 12-60 with higher scores indicating more mistrust
Measured: 12 months postpartum
Health literacy
Rapid Estimate of Adult Literacy in Medicine (REALM); scores 0-66; higher score indicates high literacy
Measured: 12 months postpartum
Self-efficacy
PROMIS General Self-Efficacy; scores range 5-50; higher score indicates higher self-efficacy
Measured: 12 months postpartum
Healthcare costs
total cost of healthcare from Medicaid Claims Database within the first 12 months after delivery
Measured: 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start29 May 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elizabeth F Sutton, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Donaghue Medical Research Foundation
- Responsible party
- Sponsor-investigator, Elizabeth F Sutton, PhD, Woman's
- Investigators
- Elizabeth Sutton, PhD, Principal investigator, Woman's Hospital, Louisiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298214
- Sponsor's protocol ID
- RP-23-019
- Acronym
- Her Health
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester
- ClinicalTrials.gov ID
- NCT06298214
- Acronym / sponsor ID
- Her Health / RP-23-019
- Conditions
- Postpartum, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Elizabeth F Sutton, PhDUniversity, hospital or other
- Collaborators
- Donaghue Medical Research Foundation
- Study start
- 29 May 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Subjects will see doctors as normal during first year postpartum with no assistance. |
| Her Health Program | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Her Health ProgramAddition of a community health worker navigator to assist subject in navigating their health in the first year postpartum. | Behavioural | Her Health Program |
Primary outcome
Postpartum visit attendance
Time frame: 12 weeks postpartum
Visit attended between 6-12 weeks of delivery (yes/no)
4 secondary outcomes
Medical trust
Time frame: 12 months postpartum
Health literacy
Time frame: 12 months postpartum
Self-efficacy
Time frame: 12 months postpartum
Healthcare costs
Time frame: 12 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Sutton, PhD principal investigator
Woman's Hospital, Louisiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Her Health Program in people with Postpartum and Pregnancy Related, run by Elizabeth F Sutton, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum visit attendance (time frame: 12 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.