NCT02727543

Brief Summary

The purpose of this study is to evaluate the impact of the Medisafe smartphone application on blood pressure control and self-reported medication adherence for patients with uncontrolled blood pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
413

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

March 31, 2016

Last Update Submit

January 17, 2017

Conditions

Hypertension

Keywords

HypertensionmHealthMedication Non-adherence

Outcome Measures

Primary Outcomes (2)

  • Change in systolic blood pressure

    Three months after randomization

  • Self-reported medication adherence

    Three months after randomization

Secondary Outcomes (1)

  • Change in number of subjects who have well controlled blood pressure

    Three months after randomization

Study Arms (2)

Control

NO INTERVENTION

Participants randomized to this arm will not receive the intervention.

Intervention

EXPERIMENTAL

Participants randomized to this arm will receive the intervention, Medisafe, a smartphone application.

Other: Medisafe

Interventions

MedisafeOTHER

Medisafe is a smartphone application available to download for free on any iOS or Android device. Medisafe addresses non-adherence by providing alerts to patients when it is time to take their medications. Other features include the ability to allow a "Medfriend" to check in if a medication is not taken, weekly reports of medication adherence, and monitoring of biometric measurements

Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 18 - 75 years of age
  • Self-reported systolic blood pressure greater than or equal to 140 mmHg
  • Self-reported use of 1-3 of the following anti-hypertensive medications (thiazide, CCB, beta-blocker, ACE-I, ARB)
  • Systolic blood pressure greater than or equal to140 mmHg (+/- diastolic blood pressure greater than or equal to 90 mmHg), but blood pressure less than or equal to 180/120 mmHg confirmed by home BP-cuff

You may not qualify if:

  • Current use of a smartphone medication adherence application
  • No ownership of a smartphone with iOS or Android operating system
  • Currently taking more than 3 anti-hypertensive medications (thiazide, CCB, beta-blocker, ACE-I, ARB) by self report
  • Currently undergoing dialysis
  • Currently receiving chemotherapy or radiation
  • Does not understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evidation Health

Menlo Park, California, 94025, United States

Location

Related Publications (1)

  • Morawski K, Ghazinouri R, Krumme A, Lauffenburger JC, Lu Z, Durfee E, Oley L, Lee J, Mohta N, Haff N, Juusola JL, Choudhry NK. Association of a Smartphone Application With Medication Adherence and Blood Pressure Control: The MedISAFE-BP Randomized Clinical Trial. JAMA Intern Med. 2018 Jun 1;178(6):802-809. doi: 10.1001/jamainternmed.2018.0447.

    PMID: 29710289DERIVED

MeSH Terms

Conditions

HypertensionMedication Adherence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Niteesh K Choudhry, MD, PhD

    Center for Healthcare Delivery Sciences, Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Harvard Medical School and Executive Director, Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 4, 2016

Study Start

April 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 18, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)