Improving Adherence to Home Blood Pressure Monitoring With Pharmacist Support
Primary Purpose
Hypertension
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weekly check-in
Sponsored by

About this trial
This is an interventional supportive care trial for Hypertension
Eligibility 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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
With check-ins
Without check-ins
Arm Description
Daily blood pressure monitoring with weekly check-ins
Daily blood pressure monitoring without weekly check-ins
Outcomes
Primary Outcome Measures
Change in adherence to home blood pressure monitoring
Proportion of days blood pressure is measured based on data from the blood pressuring monitor
Change in proportion of participants with a blood pressure <130/80 mm Hg.
Proportion of participants with a blood pressure <130/80 mm Hg.
Secondary Outcome Measures
Full Information
NCT ID
NCT04577131
First Posted
September 30, 2020
Last Updated
January 12, 2021
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT04577131
Brief Title
Improving Adherence to Home Blood Pressure Monitoring With Pharmacist Support
Official Title
Improving Adherence to Home Blood Pressure Monitoring With Pharmacist Support
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
The tracker application has been withdrawn by developer and no other suitable tracker application has been identified to replace it.
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 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
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this research study is to evaluate the impact of monitoring blood pressure from home everyday with pharmacist support.
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.
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
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
With check-ins
Arm Type
Experimental
Arm Description
Daily blood pressure monitoring with weekly check-ins
Arm Title
Without check-ins
Arm Type
No Intervention
Arm Description
Daily blood pressure monitoring without weekly check-ins
Intervention Type
Behavioral
Intervention Name(s)
Weekly check-in
Intervention Description
Weekly check-in phone calls from a pharmacist to review blood pressures and the number of times tested in that week
Primary Outcome Measure Information:
Title
Change in adherence to home blood pressure monitoring
Description
Proportion of days blood pressure is measured based on data from the blood pressuring monitor
Time Frame
1 month
Title
Change in proportion of participants with a blood pressure <130/80 mm Hg.
Description
Proportion of participants with a blood pressure <130/80 mm Hg.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving Adherence to Home Blood Pressure Monitoring With Pharmacist Support
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