A Pharmacist Intervention to Improve Mother and Child Health

Hypertension Clinical Trial

Official title:

A Pharmacist Intervention to Improve Mother and Child Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073054
• Other study ID #: 202305322
• Secondary ID: 1UM1TR004403-01
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: University of Iowa
• Contact: Hao Tran, MD
• Phone: 319-356-7825
• Email: hao-tran[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• arm circumference > 17 inches,

• prisoner status

• unable to provide own written informed consent

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Research Pharmacist
The goal of this intervention is to determine if contact with the research pharmacist will improve the health of the mother and/or child.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 30 days
Primary	Number of Participants Who Return BP Measurements	We will calculate the number of participants who return blood pressure measurements via text message.	Through study completion, an average of 30 days
Primary	Percentage of Well-Child Visits Attended	We will calculate the percentage of well-child visits that are attended by each family.	Through study completion, an average of 30 days
Primary	Percentage of Vaccinations Received	We will calculate the percentage of vaccinations received by each child.	Through study completion, an average of 30 days
Secondary	Number of BP Measurements Submitted	We will calculate the number of blood pressure values that are submitted by each participant.	Through study completion, an average of 30 days
Secondary	Blood Pressure Control	We will determine how many participants' blood pressure is controlled after the intervention.	Through study completion, an average of 30 days
Secondary	Study Satisfaction	We will measure participant satisfaction with the study using an exit survey.	Through study completion, an average of 30 days