A Pharmacist Intervention to Improve Mother and Child Health

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 Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Research Pharmacist

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shelby Francis, PhD; Phone Number: 319-678-8037; Email: shelby-francis@uiowa.edu
• Study Contact Backup: Name: Hao Tran, MD; Phone Number: 319-356-7825; Email: hao-tran@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Hospitals and Clinics
      • Contact: Shelby Francis, PhD; Phone Number: 319-678-8037; Email: shelby-francis@uiowa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Research Pharmacist Monitoring; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Percentage of Vaccinations Received	We will calculate the percentage of vaccinations received by each child.	Through study completion, an average of 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Blood Pressure Control	We will determine how many participants' blood pressure is controlled after the intervention.	Through study completion, an average of 30 days
Study Satisfaction	We will measure participant satisfaction with the study using an exit survey.	Through study completion, an average of 30 days

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Hao Tran, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 202305322; 1UM1TR004403-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No