Use of Allied-health Professionals to Improve Treatment of Disease

Preeclampsia Clinical Trial

Official title:

Use of Non-physician Allied-health Professionals to Recruit (and Follow) Research Participants, Sustain Engagement, and Improve and Diagnose Treatment of Diseases by Facilitating Transitions of Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06337799
• Other study ID #: 202210411
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2026
• Est. completion date: March 2030

Study information

• Verified date: March 2024
• Source: University of Iowa
• Contact: Philip M Polgreen, MD
• Phone: 319-384-6194
• Email: philip-polgreen[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2030
• Est. primary completion date: March 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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