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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06073054




Registration number
NCT06073054
Ethics application status
Date submitted
22/09/2023
Date registered
10/10/2023
Date last updated
1/10/2024

Titles & IDs
Public title
A Pharmacist Intervention to Improve Mother and Child Health
Scientific title
A Pharmacist Intervention to Improve Mother and Child Health
Secondary ID [1] 0 0
1UM1TR004403-01
Secondary ID [2] 0 0
202305322
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Research Pharmacist

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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Talk to Research Pharmacist
Timepoint [1] 0 0
Through study completion, an average of 30 days
Primary outcome [2] 0 0
Number of Participants Who Return BP Measurements
Timepoint [2] 0 0
Through study completion, an average of 30 days
Primary outcome [3] 0 0
Percentage of Well-Child Visits Attended
Timepoint [3] 0 0
Through study completion, an average of 30 days
Primary outcome [4] 0 0
Percentage of Vaccinations Received
Timepoint [4] 0 0
Through study completion, an average of 30 days
Secondary outcome [1] 0 0
Number of BP Measurements Submitted
Timepoint [1] 0 0
Through study completion, an average of 30 days
Secondary outcome [2] 0 0
Blood Pressure Control
Timepoint [2] 0 0
Through study completion, an average of 30 days
Secondary outcome [3] 0 0
Study Satisfaction
Timepoint [3] 0 0
Through study completion, an average of 30 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* arm circumference > 17 inches,
* prisoner status
* unable to provide own written informed consent

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/07/2024
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Iowa

Funding & Sponsors
Primary sponsor type
Other
Name
University of Iowa
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Center for Advancing Translational Sciences (NCATS)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06073054
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Hao Tran, MD
Address 0 0
University of Iowa
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06073054