A Pharmacist Intervention to Improve Mother and Child Health

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06073054

Enrollment

Registered

2023-10-10

Start date

2024-01-30

Completion date

2024-07-10

Last updated

2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

BEHAVIORALResearch 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Who Talk to Research Pharmacist	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	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	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	Through study completion, an average of 30 days	We will calculate the percentage of vaccinations received by each child.

Secondary

Measure	Time frame	Description
Blood Pressure Control	Through study completion, an average of 30 days	We will determine how many participants' blood pressure is controlled after the intervention.
Number of Participants Satisfied With the Study	Through study completion, an average of 30 days	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....
Number of BP Measurements Submitted	Through study completion, an average of 30 days	We will calculate the number of blood pressure values that are submitted by each participant.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. 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.	25
Total	25

Arm

Count

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. 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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Research Pharmacist Monitoring
Age, Continuous	32.4 years STANDARD_DEVIATION 4.8
Education Bachelor's	11 Participants
Education Doctoral Degree	2 Participants
Education High School	1 Participants
Education Master's	6 Participants
Education Some College/Associate's	5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Black or African American	3 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants
Race (NIH/OMB) White	17 Participants
Sex: Female, Male Female	25 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 25
other Total, other adverse events	0 / 25
serious Total, serious adverse events	0 / 25

Outcome results

Primary

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.