Back to results24-Hour Ambulatory Blood Pressure Monitoring in Community Pharmacies
Primary Purpose
Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ABPM service by Pharmacists
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension
Eligibility 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.
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: 24-hour ABPM by Pharmacists
Arm Description
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.
Outcomes
Primary Outcome Measures
Patient satisfaction with the pharmacy service and experience wearing the ABPM
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03920956
First Posted
April 16, 2019
Last Updated
February 4, 2020
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT03920956
Brief Title
24-Hour Ambulatory Blood Pressure Monitoring in Community Pharmacies
Official Title
Implementation & Evaluation of a 24-Hour Ambulatory Blood Pressure Monitoring Service in Community Pharmacies
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
January 24, 2020 (Actual)
Study Completion Date
January 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: 24-hour ABPM by Pharmacists
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ABPM service by Pharmacists
Intervention Description
Patients will receive ABPM services provided by a pharmacist and complete a patient satisfaction survey
Primary Outcome Measure Information:
Title
Patient satisfaction with the pharmacy service and experience wearing the ABPM
Description
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.
Time Frame
up to 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dave Dixon, PharmD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23236
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33180905
Citation
Khaddage SJ, Patterson JA, Sargent LJ, Price ET, Dixon DL. Sex and Age Differences in Ambulatory Blood Pressure Monitoring Tolerability. Am J Hypertens. 2021 Apr 20;34(4):335-338. doi: 10.1093/ajh/hpaa182.
Results Reference
derived
Learn more about this trial
24-Hour Ambulatory Blood Pressure Monitoring in Community Pharmacies
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