Use of Allied-health Professionals to Improve Treatment of Disease

NCT ID: NCT06337799

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-10-31
• Study Completion Date: 2030-03-31

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.

Detailed Description

After consent, a research pharmacist will virtually monitor the participant's blood pressure until the 12-month follow up visit. The research pharmacists will have access to the participant's electronic medical records to monitor and document medications and clinic blood pressures for analysis . Participants will be asked to measure and return 14 blood pressure measurements (2x per day for 7 days) using our text messaging platform. They will be allowed to choose the times that they are sent reminders to measure their blood pressure. If a participant has blood pressure values sufficient for a hypertension diagnosis, the pharmacist will communicate via electronic medical record with the participant's primary care team. If they do not have a primary care provider, the pharmacist will facilitate finding one. The pharmacist will continue monitoring the participant and making recommendations to the primary care team through the electronic medical record to quickly adjust therapy to improve blood pressure control. The pharmacists will typically contact the participants (via participant's choice of phone, text, or email) every 2-3 weeks while their hypertension is uncontrolled. Once under control, the pharmacist will continue to contact the participant at least every 2 months to support adherence and reassess control.

Conditions

Preeclampsia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Research Pharmacist Monitoring

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.

Group Type: EXPERIMENTAL

Research Pharmacist

Intervention Type: BEHAVIORAL

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

Interventions

Research Pharmacist

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Philip Polgreen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip M Polgreen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Central Contacts

Philip M Polgreen, MD

Role: CONTACT

philip-polgreen@uiowa.edu

319-384-6194

Shelby L Francis, PhD

Role: CONTACT

shelby-francis@uiowa.edu

319-678-8037

Other Identifiers

202210411

Identifier Type: -

Identifier Source: org_study_id