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Improving Adherence to Home Blood Pressure Monitoring With Pharmacist Support

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04577131
Recruitment Status : Terminated (The tracker application has been withdrawn by developer and no other suitable tracker application has been identified to replace it.)
First Posted : October 6, 2020
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
The purpose of this research study is to evaluate the impact of monitoring blood pressure from home everyday with pharmacist support.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Weekly check-in Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Adherence to Home Blood Pressure Monitoring With Pharmacist Support
Actual Study Start Date : November 5, 2020
Actual Primary Completion Date : November 5, 2020
Actual Study Completion Date : November 5, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04577131


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Dave Dixon, PharmD Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04577131    
Other Study ID Numbers: HM20019041
First Posted: October 6, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases