Using Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions

Using Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions to Manage Uncontrolled Hypertension in the Community Setting - A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Telehealth Follow-up Visits; Behavioral: Surveys; Device: Devices

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • USF Pharmacy Plus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Home blood pressure monitoring; 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

Behavioral: Telehealth Follow-up Visits; • 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; Behavioral: Surveys; 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; Device: Devices; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine if pharmacists' interventions improved BP	BP readings were reported and evaluated to discover if these were improved with pharmacists' interventions.	8 weeks

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: National Association of Chain Drug Stores
• Investigators: Principal Investigator: Wendy H Updike, PharmD, University of South Florida College of Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: Pro00036888

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes