NCT06337799

Brief Summary

The goal of this clinical trial is to learn if allied-health professionals can recruit and follow research participants, sustain engagement, and improve and diagnose treatment of diseases by facilitating transitions of care. Participants will: Take their blood pressure at home and return it to the research team; Follow up with a research pharmacist for 12 months; Return for a follow up visit after 12 months.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
42mo left

Started Oct 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
2.5 years until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

3.4 years

First QC Date

March 22, 2024

Last Update Submit

May 30, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Number of Subjects at Risk for Hypertension

    We will calculate the number of participants who are at risk for hypertension during the course of the intervention.

    Through study completion, an average of 12 months

  • Number of Subjects Exposed to a Screening Clinic

    We will calculate the number of participants who visited a screening clinic during the course of the intervention.

    Through study completion, an average of 12 months

  • Number of Subjects Screened at a Screening Clinic

    We will calculate the number of participants who were screened at a screening clinic during the intervention.

    Through study completion, an average of 12 months

  • Number of Subjects Followed-Up by the Research Pharmacist

    We will calculated the number of participants who were followed-up by a research pharmacist during the intervention.

    Through study completion, an average of 12 months

  • Number of Subjects Diagnosed with Hypertension

    We will calculate the number of participants who were diagnosed with hypertension by their provider during the intervention.

    Through study completion, an average of 12 months

  • Number of Subjects Treated for Hypertension, if Diagnosed

    We will calculate the number of participants who were treated for their hypertension diagnosis by their provider, if they were diagnosed with hypertension, during the intervention.

    Through study completion, an average of 12 months

Study Arms (1)

Research Pharmacist Monitoring

EXPERIMENTAL

The research pharmacist will help the mother find a primary care physician if she doesn't have one and discuss strategies to lower blood pressure, if needed. The pharmacist interactions will occur 7 days after enrollment and then approximately every 2 weeks to 2 months during 12 months of follow up, depending on blood pressure control. They may 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.

Behavioral: Research Pharmacist

Interventions

The goal of this intervention is to determine if allied health professionals will improve blood pressure in new mothers.

Research Pharmacist Monitoring

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Biological mothers delivering at UIHC or attending a well-child visit for an infant between 1 month and 9 months
  • Preeclampsia during pregnancy
  • Preceived prenatal care at UIHC
  • Owns a smartphone

You may not qualify if:

  • Arm circumference greater than 17 inches
  • Prisoner status
  • Unable to provide own written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Philip M Polgreen, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip M Polgreen, MD

CONTACT

Shelby L Francis, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2024

First Posted

March 29, 2024

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Last Updated

May 31, 2025

Record last verified: 2025-05