Using Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions

NCT ID: NCT05606783

Last Updated: 2022-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-23

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Telehealth Follow-up Visits

Intervention Type BEHAVIORAL

• 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

Surveys

Intervention Type BEHAVIORAL

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

Devices

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Association of Chain Drug Stores

INDUSTRY

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendy H Updike, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida College of Pharmacy

Locations

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USF Pharmacy Plus

Tampa, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00036888

Identifier Type: -

Identifier Source: org_study_id

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