Using Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05606783
• Other study ID #: Pro00036888
• Status: Completed
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2019
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension

Intervention

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
• 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

Locations

Country	Name	City	State
United States	USF Pharmacy Plus	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Association of Chain Drug Stores

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine if pharmacists' interventions improved BP	BP readings were reported and evaluated to discover if these were improved with pharmacists' interventions.	8 weeks