Optimizing the Approach of Mobile Application Use to Improve Medication Adherence in Patients With Hypertension

August 28, 2019 updated by: Mercer University
The purpose of this study was to determine the effectiveness of using a custom-designed mobile application to improve blood pressure (BP) and promote adherence to antihypertensive medication regimens. This was a prospective, multicenter, randomized controlled trial. Patients were randomized to an intervention or control group for three months. Antihypertensive medication refill history was assessed three months before, during and three months after the study period. Continuous outcome measures investigated were systolic/diastolic BP and medication refill history, using the cumulative medication gap (CMG) score.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age
  • Diagnosed with hypertension as evidenced by diagnosis codes or chart documentation
  • Prescribed at least one antihypertensive for a minimum of three months prior to enrollment
  • Have access to an Android mobile device with data capabilities
  • Consent to using the application on their device

Exclusion Criteria:

  • Do not read or speak English
  • Unable to read and sign the informed consent or Health Insurance Privacy and Accountability Act (HIPAA) waiver
  • Too ill or cognitively impaired to participate

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Other: Intervention
Mobile application intervention
Other: Mobile application (BP-n-Me)
The mobile app consisted of a series of features including (1) calendar reminders of when to take medications and the patient's antihypertensive medication regimen (2) a "Call your Pharmacist" button specific to patient's pharmacy, (3) a BP log in which the patient could enter blood pressure values that were automatically compared to goal values, (4) counseling points for lifestyle and adherence factors individually tailored to each patient and (5) lifestyle and medication adherence surveys.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence
Time Frame: 6 months
This was assessed based on cumulative medication gap (CMG)
6 months
Blood pressure
Time Frame: 6 months
This was assessed by measuring the change of systolic and diastolic blood pressure
6 months

Collaborators and Investigators

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

Sponsor

Mercer University

Collaborators

Grady Health System
Emory Healthcare
Atlanta Medical Center

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 (Actual)

October 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

August 21, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1605145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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