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Using Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions

Sponsor
University of South Florida (Other)
Overall Status
Completed
CT.gov ID
NCT05606783
Collaborator
National Association of Chain Drug Stores (Industry)
9
Enrollment
1
Location
1
Arm
5.2
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Telehealth Follow-up Visits
  • Behavioral: Surveys
  • Device: Devices
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Using Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions to Manage Uncontrolled Hypertension in the Community Setting - A Pilot Study
Actual Study Start Date :
Jan 23, 2019
Actual Primary Completion Date :
Apr 30, 2019
Actual Study Completion Date :
Jun 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Comfort [8 weeks]

    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

  1. Determine if pharmacists' interventions improved BP [8 weeks]

    BP readings were reported and evaluated to discover if these were improved with pharmacists' interventions.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 USF Pharmacy Plus Tampa Florida United States 33612

Sponsors and Collaborators

  • University of South Florida
  • National Association of Chain Drug Stores

Investigators

  • Principal Investigator: Wendy H Updike, PharmD, University of South Florida College of Pharmacy

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
University of South Florida
ClinicalTrials.gov Identifier:
NCT05606783
Other Study ID Numbers:
  • Pro00036888
First Posted:
Nov 7, 2022
Last Update Posted:
Nov 7, 2022
Last Verified:
Jan 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Nov 7, 2022