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A Pharmacist Intervention to Improve Mother and Child Health

Primary Purpose

Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Research Pharmacist
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hypertension

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: biological mother of a baby attending a 1-week to 4-month well-child visit, received prenatal care at University of Iowa Hospitals and Clinics, had at least 2 elevated blood pressures (>= 140 mmHg systolic or >= 90 mmHg diastolic) during pregnancy, owns a smartphone Exclusion Criteria: arm circumference > 17 inches, prisoner status unable to provide own written informed consent

Sites / Locations

  • University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Research Pharmacist Monitoring

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Number of Participants Who Return BP Measurements
We will calculate the number of participants who return blood pressure measurements via text message.
Percentage of Well-Child Visits Attended
We will calculate the percentage of well-child visits that are attended by each family.
Percentage of Vaccinations Received
We will calculate the percentage of vaccinations received by each child.

Secondary Outcome Measures

Number of BP Measurements Submitted
We will calculate the number of blood pressure values that are submitted by each participant.
Blood Pressure Control
We will determine how many participants' blood pressure is controlled after the intervention.
Study Satisfaction
We will measure participant satisfaction with the study using an exit survey.

Full Information

First Posted
September 22, 2023
Last Updated
October 2, 2023
Sponsor
University of Iowa
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT06073054
Brief Title
A Pharmacist Intervention to Improve Mother and Child Health
Official Title
A Pharmacist Intervention to Improve Mother and Child Health
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Research Pharmacist Monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Research Pharmacist
Intervention Description
The goal of this intervention is to determine if contact with the research pharmacist will improve the health of the mother and/or child.
Primary Outcome Measure Information:
Title
Number of Participants Who Talk to Research Pharmacist
Description
We will calculate the number of participants who talk to the research pharmacist during the course of the intervention.
Time Frame
Through study completion, an average of 30 days
Title
Number of Participants Who Return BP Measurements
Description
We will calculate the number of participants who return blood pressure measurements via text message.
Time Frame
Through study completion, an average of 30 days
Title
Percentage of Well-Child Visits Attended
Description
We will calculate the percentage of well-child visits that are attended by each family.
Time Frame
Through study completion, an average of 30 days
Title
Percentage of Vaccinations Received
Description
We will calculate the percentage of vaccinations received by each child.
Time Frame
Through study completion, an average of 30 days
Secondary Outcome Measure Information:
Title
Number of BP Measurements Submitted
Description
We will calculate the number of blood pressure values that are submitted by each participant.
Time Frame
Through study completion, an average of 30 days
Title
Blood Pressure Control
Description
We will determine how many participants' blood pressure is controlled after the intervention.
Time Frame
Through study completion, an average of 30 days
Title
Study Satisfaction
Description
We will measure participant satisfaction with the study using an exit survey.
Time Frame
Through study completion, an average of 30 days

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: biological mother of a baby attending a 1-week to 4-month well-child visit, received prenatal care at University of Iowa Hospitals and Clinics, had at least 2 elevated blood pressures (>= 140 mmHg systolic or >= 90 mmHg diastolic) during pregnancy, owns a smartphone Exclusion Criteria: arm circumference > 17 inches, prisoner status unable to provide own written informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Tran, MD
Phone
319-356-7825
Email
hao-tran@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shelby Francis, PhD
Phone
319-678-8037
Email
shelby-francis@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Tran, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelby Francis, PhD
Phone
319-678-8037
Email
shelby-francis@uiowa.edu

12. IPD Sharing Statement

Learn more about this trial

A Pharmacist Intervention to Improve Mother and Child Health

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