NCT04066010

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

August 21, 2019

Last Update Submit

August 28, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Medication adherence

    This was assessed based on cumulative medication gap (CMG)

    6 months

  • Blood pressure

    This was assessed by measuring the change of systolic and diastolic blood pressure

    6 months

Study Arms (2)

Control

NO INTERVENTION

Intervention

OTHER

Mobile application intervention

Other: Mobile application (BP-n-Me)

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.

MeSH Terms

Conditions

Medication AdherenceHypertension

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 22, 2019

Study Start

October 1, 2016

Primary Completion

May 1, 2018

Study Completion

November 1, 2018

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share