Using Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions

NCT05606783 | Completed FDA Device

• 1 other identifier: Pro00036888
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine if pharmacists' interventions improved BP

  8 weeks

Study Arms (1)

Home blood pressure monitoring

EXPERIMENTAL

* 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; Behavioral: Surveys; Device: Devices

Interventions

Telehealth Follow-up Visits 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

Home blood pressure monitoring

Surveys 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

Home blood pressure monitoring

Devices 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

Home blood pressure monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of South Florida: lead
• National Association of Chain Drug Stores: collaborator

Study Sites (1)

USF Pharmacy Plus

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Surveys and Questionnaires; Equipment and Supplies

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Wendy H Updike, PharmD

  University of South Florida College of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: November 7, 2022
• Study Start: January 23, 2019
• Primary Completion: April 30, 2019
• Study Completion: June 30, 2019
• Last Updated: November 7, 2022

Record last verified: 2019-01

Locations

US (1)