HypertensionNCT06073054
A Pharmacist Intervention to Improve Mother and Child Health
A study testing Research Pharmacist in people with Hypertension, run by University of Iowa at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a research pharmacist can improve the health of new mothers and their babies. The main questions it aims to answer are: Will postpartum women who had elevated blood pressure during pregnancy be willing to participate in the study, talk to a pharmacist about their health… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- Research Pharmacist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- biological mother of a baby attending a 1-week to 6-month well-child visit,
- received prenatal care at University of Iowa Hospitals and Clinics,
- had at least 2 elevated blood pressures (>= 130 mmHg systolic or >= 80 mmHg diastolic) during pregnancy,
- owns a smartphone
Who cannot join
- arm circumference > 17 inches,
- prisoner status
- unable to provide own written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
The goal of this clinical trial is to learn if a research pharmacist can improve the health of new mothers and their babies. The main questions it aims to answer are:
- Will postpartum women who had elevated blood pressure during pregnancy be willing to participate in the study, talk to a pharmacist about their health and the health of their child, and text us their blood pressure measurements?
- Will contact with the pharmacist improve the health of the mother and/or the child?
Read more
Participants will:
- complete a baseline demographic survey,
- be given a blood pressure cuff and taught how to use it,
- be asked to text us their blood pressure values 2 times per day for 7 days after enrollment,
- complete a phone call with a pharmacist discussing their health and the health of their baby,
- text us their blood pressure 1 time per day for 3 days 1 month after enrollment,
- have a 1 month follow-up phone call with the research pharmacist, and
- complete an exit survey to provide feedback about the study.
- Conditions
- Hypertension
- Being tested
- Research Pharmacist
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research PharmacistBehavioural
The goal of this intervention is to determine if contact with the research pharmacist will improve the health of the mother and/or child.
| Study group | Role | What they receive |
|---|---|---|
| Research Pharmacist Monitoring | Experimental | The pharmacist will help the mother find a primary care physician if she doesn't have one, obtain health insurance if she doesn't have any, and discuss any health-related information about herself or her child, as needed. These pharmacist interactions will occur 7 days after baseline and again 1 month later (the participant will be asked to measure and text their blood pressure again 1 time per day for 3 days during the follow-up month). If the participant's blood pressures become elevated, the pharmacist will provide behavioral and lifestyle interventions to attempt to lower the blood pressure. They may also recommend medications to the participant's physician. The pharmacist will have access to the participant's electronic medical record to obtain any blood pressure-related medications that the mother is prescribed as well as throughout the follow up to ensure any health-related conditions can be discussed, as necessary. Receives: Behavioral: Research Pharmacist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Talk to Research Pharmacist
We will calculate the number of participants who talk to the research pharmacist during the course of the intervention.
Measured: Through study completion, an average of 30 days
Number of Participants Who Return BP Measurements
We will calculate the number of participants who return at least one blood pressure measurement via text message.
Measured: Through study completion, an average of 30 days
Percentage of Well-Child Visits Attended
We will calculate the percentage of well-child visits that are attended by each family.
Measured: Through study completion, an average of 30 days
Percentage of Vaccinations Received
We will calculate the percentage of vaccinations received by each child.
Measured: Through study completion, an average of 30 days
Secondary outcomes (3)
Number of BP Measurements Submitted
We will calculate the number of blood pressure values that are submitted by each participant.
Measured: Through study completion, an average of 30 days
Blood Pressure Control
We will determine how many participants' blood pressure is controlled after the intervention.
Measured: Through study completion, an average of 30 days
Number of Participants Satisfied With the Study
We will measure participant satisfaction with the study using an exit survey. Satisfaction will be measured by a response of Extremely Helpful or Helpful on the question- My contact(s) with the pharmacist about my health were....
Measured: Through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start30 Jan 2024
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Hao P. Tran, University of Iowa
- Investigators
- Hao Tran, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073054
- Sponsor's protocol ID
- 202305322
- Other IDs
- 1UM1TR004403-01
- Status last verified
- Aug 2025
- First submitted
- 22 Sep 2023
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacist Intervention to Improve Mother and Child Health
- ClinicalTrials.gov ID
- NCT06073054
- Acronym / sponsor ID
- 202305322
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Posted 29 Aug 2025
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 research pharmacist can improve the health of new mothers and their babies. The main questions it aims to answer are:
- Will postpartum women who had elevated blood pressure during pregnancy be willing to participate in the study, talk to a pharmacist about their health and the health of their child, and text us their blood pressure measurements?
- Will contact with the pharmacist improve the health of the mother and/or the child?
Participants will:
- complete a baseline demographic survey,
- be given a blood pressure cuff and taught how to use it,
- be asked to text us their blood pressure values 2 times per day for 7 days after enrollment,
- complete a phone call with a pharmacist discussing their health and the health of their baby,
- text us their blood pressure 1 time per day for 3 days 1 month after enrollment,
- have a 1 month follow-up phone call with the research pharmacist, and
- complete an exit survey to provide feedback about the study.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research Pharmacist Monitoring | Experimental | Behavioral: Research PharmacistThe pharmacist will help the mother find a primary care physician if she doesn't have one, obtain health insurance if she doesn't have any, and discuss any health-related information about herself or her child, as needed. These pharmacist interactions will occur 7 days after baseline and again 1 month later (the participant will be asked to measure and text their blood pressure again 1 time per day for 3 days during the follow-up month). If the participant's blood pressures become elevated, the pharmacist will provide behavioral and lifestyle interventions to attempt to lower the blood pressure. They may also recommend medications to the participant's physician. The pharmacist will have access to the participant's electronic medical record to obtain any blood pressure-related medications that the mother is prescribed as well as throughout the follow up to ensure any health-related conditions can be discussed, as necessary. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- biological mother of a baby attending a 1-week to 6-month well-child visit,
- received prenatal care at University of Iowa Hospitals and Clinics,
- had at least 2 elevated blood pressures (>= 130 mmHg systolic or >= 80 mmHg diastolic) during pregnancy,
- owns a smartphone
Key exclusion criteria (3 listed)
- arm circumference > 17 inches,
- prisoner status
- unable to provide own written 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 |
|---|---|---|
| Research PharmacistThe goal of this intervention is to determine if contact with the research pharmacist will improve the health of the mother and/or child. | Behavioural | Research Pharmacist Monitoring |
Primary outcome
Number of Participants Who Talk to Research Pharmacist
Time frame: Through study completion, an average of 30 days
We will calculate the number of participants who talk to the research pharmacist during the course of the intervention.
Number of Participants Who Return BP Measurements
Time frame: Through study completion, an average of 30 days
We will calculate the number of participants who return at least one blood pressure measurement via text message.
Percentage of Well-Child Visits Attended
Time frame: Through study completion, an average of 30 days
We will calculate the percentage of well-child visits that are attended by each family.
Percentage of Vaccinations Received
Time frame: Through study completion, an average of 30 days
We will calculate the percentage of vaccinations received by each child.
3 secondary outcomes
Number of BP Measurements Submitted
Time frame: Through study completion, an average of 30 days
Blood Pressure Control
Time frame: Through study completion, an average of 30 days
Number of Participants Satisfied With the Study
Time frame: Through study completion, an average of 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Hao Tran, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Research Pharmacist in people with Hypertension, run by University of Iowa 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Aug 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?
Yes. Results are posted in the registry (first posted 29 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Talk to Research Pharmacist (time frame: Through study completion, an average of 30 days). The study lists 4 primary outcomes in all. 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 29 Aug 2025.