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24-Hour Ambulatory Blood Pressure Monitoring in Community Pharmacies

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: NCT03920956
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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Brief Summary:
This study is designed to explore the feasibility of providing 24-hour ambulatory blood pressure monitoring in community pharmacies. The investigators hypothesize it will be feasible for community pharmacies to provide the service to assist medical providers in the diagnosing and management of high blood pressure. The investigators will also survey participants regarding their experience with the service as well as conduct interviews with participating pharmacists and medical providers to understand their views and opinions on the feasibility of the service.

Condition or disease Intervention/treatment Phase
Hypertension Other: ABPM service by Pharmacists Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementation & Evaluation of a 24-Hour Ambulatory Blood Pressure Monitoring Service in Community Pharmacies
Actual Study Start Date : July 24, 2019
Actual Primary Completion Date : January 24, 2020
Actual Study Completion Date : January 24, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: 24-hour ABPM by Pharmacists
Patients will meet with the pharmacist to be equipped with a 24-hour ambulatory blood pressure monitor (ABPM). Patients will return the monitor for the pharmacists to download the results to send to their medical provider.
 Other: ABPM service by Pharmacists
Patients will receive ABPM services provided by a pharmacist and complete a patient satisfaction survey


Outcome Measures
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Primary Outcome Measures :
  1. Patient satisfaction with the pharmacy service and experience wearing the ABPM [ Time Frame: up to 72 hours ]
    Patient satisfaction will be assessed using a 9 item survey. Participants will rate items on a 5-point scale from strongly agree to strongly disagree.


Eligibility Criteria
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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:

  • Adults greater than or equal to 18 years of age suspected by their physician of having "white coat" or "masked" hypertension (HTN), hypotension symptoms due to antihypertensive therapy, uncontrolled sustained HTN, requiring additional confirmation of an initial diagnosis if HTN, or resistant HTN.

Exclusion Criteria:

  • Documented past medical history of persistent atrial fibrillation, on hemodialysis, pregnancy, or dementia.
Contacts and Locations
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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): NCT03920956


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23236
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Dave Dixon, PharmD Virginia Commonwealth University
More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03920956    
Other Study ID Numbers: HM20015789
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
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
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases