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NCT04066010 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04066010
Other study ID # H1605145
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date November 2018

Study information
Verified date August 2019
Source Mercer University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date November 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

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.

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Mercer University Atlanta Medical Center, Emory Healthcare, Grady Health System

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