Monitoring Blood Pressure at Home

Post-Emergency Department Discharge Clinic Telehealth Program for Patients With Uncontrolled Hypertension: a Pilot Study

The overall goal of this project is to determine if measuring blood pressure at home and staying in contact with a team of pharmacists and physicians to manage your blood pressure is feasible. The study will enroll 24 participants at UAB who are seen at the Emergency Department Post-Discharge Clinic. Half of the participants (12 patients) will be asked to measure their blood pressure at home, and half of the participants (12 patients) will continue to receive usual care. Participants who measure their blood pressure at home will also meet with a pharmacist weekly over the phone to discuss blood pressure readings and have blood pressure medications prescribed if needed. This program will last 3 months.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: Usual care; Other: Remote Blood Pressure Monitoring + Telehealth

Detailed Description

For all participants:

1. Participants will receive information on the importance of measuring blood pressure and ways to improve blood pressure.
2. Participants will complete questionnaires describing current socioeconomic position, medical history and healthcare needs.
3. Participants will come in for one research clinic visit to get blood pressure measured 3 months after enrollment in this study.

For participants asked to measure blood pressure at home:

1. Measure blood pressure twice a day at home, following the instructions provided. The study will provide participants with the device and send text message reminders each week day. Participants will return the device at study visit 3 months from now.
2. Following the instructions provided, participants will talk to a pharmacist over the phone weekly to discuss blood pressure and medications. All medication changes will be discussed with a collaborating physician.
3. Participants will complete questionnaires on satisfaction with the program.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients seen at the Emergency Department Post-Discharge Clinic
• >=18 years
• Blood pressure >=130/80 mmHg and <=160/100 mmHg
• English speakers
• Have a smartphone

Exclusion Criteria:

• Patients with blood pressure >=160 mmHg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual Care; Participants receive usual care from providers to manage their blood pressure	Other: Usual care; Participants receive usual care, no intervention.
Active Comparator: Remote Blood Pressure Monitoring + Telehealth; Participants will undergo remote blood pressure monitoring and pharmacist led telehealth intervention for blood pressure management	Other: Remote Blood Pressure Monitoring + Telehealth; Remote blood pressure monitoring and pharmacist led telehealth intervention for blood pressure management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Recruited Participants	Number of participants enrolled into the study after screening and eligibility confirmation.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Attended Last Study Visit	Number of participants who completed the final study visit conducted approximately three months after randomization.	3 months from randomization

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Lama Ghazi, MD, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: hypertension; blood pressure
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Health Services Administration; Delivery of Health Care; Patient Care Management; Telemedicine
• Other Study ID Numbers: IRB-300012428; P50MD017338 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No