Back to resultsUsing Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions
Primary Purpose
Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth Follow-up Visits
Surveys
Devices
Sponsored by
About this trial
This is an interventional supportive care trial for Hypertension
Eligibility Criteria
Inclusion Criteria: must be at least 18 years old have a smartphone compatible with the mobile intervention (iPhone) have been previously diagnosed with hypertension have uncontrolled hypertension (SBP > 130 mmHg and/or DBP > 80 mmHg) be under the care of a primary care physician in the Family Medicine Department of the USF Morsani Center for Advanced Care have had at least one prescription filled at Pharmacy Plus within the last six months speaks English fluently Exclusion Criteria: already under the care of a clinical pharmacist in the Family Medicine department pregnant have a serious existing medical condition(s) that may affect their ability to self-monitor their blood pressure (for example, stroke, dementia)
Sites / Locations
- USF Pharmacy Plus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Home blood pressure monitoring
Arm Description
Smart Phones with Apple Health Software will be used to monitor blood pressure once a day, and results will be sent automatically to the patients EHR (Epic) The Omron 10 Series Wireless Upper Arm Blood Pressure Device will be given to the patient to monitor blood pressure at home daily Patients will be scheduled for a one-hour in-person appointment for the initial study visit where informed consent will be obtained, and for the final study visit
Outcomes
Primary Outcome Measures
Comfort
Patient comfort in using home telemonitoring for blood pressure combined with pharmacist counseling and monitoring will be measured using a survey instrument with a Likert scale (4-point scale). (Most of the time; Some of the time; Seldom; Never) (Strongly agree; Agree; Disagree; Strongly disagree) (Nothing; Very little; Some; Knowledgeable)
Secondary Outcome Measures
Determine if pharmacists' interventions improved BP
BP readings were reported and evaluated to discover if these were improved with pharmacists' interventions.
Full Information
NCT ID
NCT05606783
First Posted
March 26, 2019
Last Updated
November 2, 2022
Sponsor
University of South Florida
Collaborators
National Association of Chain Drug Stores
1. Study Identification
Unique Protocol Identification Number
NCT05606783
Brief Title
Using Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions
Official Title
Using Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions to Manage Uncontrolled Hypertension in the Community Setting - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
National Association of Chain Drug Stores
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
Family Medicine patients with uncontrolled hypertension will be given a Bluetooth enabled home blood pressure machine to monitor their blood pressure every day for 6 weeks. The blood pressure results will be sent automatically to the patient's electronic medical record via applications on their iPhone. Study pharmacists will follow-up with the patients once per week via a telehealth appointment using the app VSee, where the blood pressure results will be reviewed. The pharmacists will also counsel the patients on lifestyle modifications in order to improve blood pressure.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home blood pressure monitoring
Arm Type
Experimental
Arm Description
Smart Phones with Apple Health Software will be used to monitor blood pressure once a day, and results will be sent automatically to the patients EHR (Epic)
The Omron 10 Series Wireless Upper Arm Blood Pressure Device will be given to the patient to monitor blood pressure at home daily
Patients will be scheduled for a one-hour in-person appointment for the initial study visit where informed consent will be obtained, and for the final study visit
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Follow-up Visits
Intervention Description
• Follow-up with patients once per week for six (6) weeks via scheduled 20-minute telehealth appointment with each patient via the HIPAA secure and compliant platform, VSee
o During this telehealth appointment, the study pharmacists will counsel the patients on their blood pressure readings for that week and provide lifestyle education focusing on patient-specific diet and exercise recommendations
Intervention Type
Behavioral
Intervention Name(s)
Surveys
Intervention Description
A pre- and post-survey will be given at the initial and final in-person appointments, respectively
• These surveys will collect basic patient demographics, knowledge of blood pressure, comfort with checking blood pressure at home, and previous experience working with a pharmacist
Intervention Type
Device
Intervention Name(s)
Devices
Intervention Description
Smart Phones with Apple Health Software will be used to monitor blood pressure once a day, and results will be sent automatically to the patients EHR (Epic)
• The Omron 10 Series Wireless Upper Arm Blood Pressure Device will be given to the patient to monitor blood pressure at home daily
Primary Outcome Measure Information:
Title
Comfort
Description
Patient comfort in using home telemonitoring for blood pressure combined with pharmacist counseling and monitoring will be measured using a survey instrument with a Likert scale (4-point scale). (Most of the time; Some of the time; Seldom; Never) (Strongly agree; Agree; Disagree; Strongly disagree) (Nothing; Very little; Some; Knowledgeable)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Determine if pharmacists' interventions improved BP
Description
BP readings were reported and evaluated to discover if these were improved with pharmacists' interventions.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
must be at least 18 years old
have a smartphone compatible with the mobile intervention (iPhone)
have been previously diagnosed with hypertension
have uncontrolled hypertension (SBP > 130 mmHg and/or DBP > 80 mmHg)
be under the care of a primary care physician in the Family Medicine Department of the USF Morsani Center for Advanced Care
have had at least one prescription filled at Pharmacy Plus within the last six months
speaks English fluently
Exclusion Criteria:
already under the care of a clinical pharmacist in the Family Medicine department
pregnant
have a serious existing medical condition(s) that may affect their ability to self-monitor their blood pressure (for example, stroke, dementia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy H Updike, PharmD
Organizational Affiliation
University of South Florida College of Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
USF Pharmacy Plus
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Using Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions
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