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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04577131
Other study ID # HM20019041
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 5, 2020
Est. completion date November 5, 2020

Study information

Verified date January 2021
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date November 5, 2020
Est. primary completion date November 5, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

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