Utilizing Consumer Health Informatics to Support Management of Hypertension by Clinical Pharmacists in Primary Care

July 13, 2020 updated by: Lorraine Buis, University of Michigan
The purpose of this research study is to test the feasibility, acceptability, and preliminary effectiveness of the use of a mobile pharmacist-led intervention that incorporates home BP monitoring and medication reminders with patients recruited from a primary care setting, as well as identify challenges and potential solutions to broader implementation of a mobile pharmacist-led home-based BP monitoring intervention in primary care clinics through key stakeholder interviews.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a smart phone compatible with mobile intervention
  • Have been previously diagnosed with hypertension
  • Have uncontrolled hypertension (systolic blood pressure > 140 and/or diastolic blood pressure > 90 on repeat measurement)
  • Be under the care of a primary care physician at the recruitment clinic
  • Be taking at least one antihypertensive medication
  • Be English speaking

Exclusion Criteria:

  • Patients under the care of a clinical pharmacist for hypertension management, or under the care of a cardiologist
  • Pregnant patients and anyone with the following unrelated, but serious medical conditions will also be excluded, as they may make blood pressure control difficult or necessitate frequent hospitalization: previous diagnosis of resistant hypertension; steroid dependent asthma or emphysema; cirrhosis or hepatic failure; stage C or D chronic heart failure; stage IV or V chronic kidney disease; and cancer (terminal or undergoing active chemotherapeutic or radiation therapy)
  • Patients with other serious medical conditions (e.g., stroke, dementia) that may affect their ability to self-monitor blood pressure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: BP Track
The study participants will be asked to monitor their blood pressure twice daily at home for twelve weeks, and sync the data to the mobile intervention so that a clinical pharmacist can review and incorporate the data into ongoing hypertension management.
Other: BP Track

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in blood pressure
Time Frame: from baseline to 12 weeks
from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in medication adherence as measured by the Adherence to Refills and Medications Scale (ARMS)
Time Frame: from baseline to 12 weeks
from baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Lorraine R Buis, PhD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MICHR T3-RIP
  • HUM00105772 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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