Improving Adherence to Home Blood Pressure Monitoring With Pharmacist Support

January 12, 2021 updated by: Virginia Commonwealth University
The purpose of this research study is to evaluate the impact of monitoring blood pressure from home everyday with pharmacist support.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

High blood pressure is very common and increases risk of heart, kidney, brain, and eye disease. It is important to diagnose and treat high blood pressure to reduce risk of these complications. Getting blood pressure checked only when someone sees a doctor is not the best way to diagnose high blood pressure or to make sure blood pressure is well managed. Checking blood pressure at home gives a better idea of whether someone's blood pressure is normal or too high.

As part of their usual blood pressure monitoring, participants will be given an Omron 3 series or 5 series blood pressure monitor which has been cleared by the US Food and Drug Administration and validated to meet accuracy and performance requirements. For one month, participants will monitor their blood pressure once a day and then return the device to the clinic at the end of the study. Participants will text their blood pressure result to the American Heart Association's Check, Change, Control (CCC) secure online tracker.

As part of the research study, participants will also be randomized to either receive or not receive weekly check-in phone calls from a pharmacist to review their blood pressures and the number of times they tested in that week. Approximately 50 individuals will participate in this study. Participation in this study will last 1 month.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age and older
  • Uncontrolled hypertension (BP > 130/80 mm Hg)

Exclusion Criteria:

  • non-English speaking patients
  • patients without a mobile phone or texting capability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With check-ins
Daily blood pressure monitoring with weekly check-ins
Behavioral: Weekly check-in
Weekly check-in phone calls from a pharmacist to review blood pressures and the number of times tested in that week
No Intervention: Without check-ins
Daily blood pressure monitoring without weekly check-ins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in adherence to home blood pressure monitoring
Time Frame: 1 month
Proportion of days blood pressure is measured based on data from the blood pressuring monitor
1 month
Change in proportion of participants with a blood pressure <130/80 mm Hg.
Time Frame: 1 month
Proportion of participants with a blood pressure <130/80 mm Hg.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Dave Dixon, PharmD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2020

Primary Completion (Actual)

November 5, 2020

Study Completion (Actual)

November 5, 2020

Study Registration Dates

First Submitted

September 30, 2020

First Submitted That Met QC Criteria

September 30, 2020

First Posted (Actual)

October 6, 2020

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20019041

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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