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Medication Adherence Improvement Support App For Engagement - Blood Pressure (MedISAFE-BP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02727543
Recruitment Status : Completed
First Posted : April 4, 2016
Last Update Posted : January 18, 2017
Sponsor:
Collaborators:
Medisafe, Inc.
Evidation Health
Information provided by (Responsible Party):
Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Other: Medisafe Not Applicable

Detailed Description:

The Medication adherence Improvement Support App For Engagement - Blood Pressure (MEDISAFE-BP) trial is a prospective, intent-to-treat randomized control trial that will evaluate the impact of the Medisafe smartphone application on blood pressure control and self-reported medication adherence for patients with uncontrolled blood pressure.

Recruitment will be conducted by Evidation Health, which uses an online strategy to virtually announce, recruit, verify eligibility and enroll participants in clinical studies. Potential study subjects will be evaluated for inclusion and exclusion criteria, will give informed consent, complete the baseline assessment, and then be sent a Bluetooth-enabled home blood pressure cuff to verify that they have uncontrolled blood pressure (systolic blood pressure ≥ 140 mmHg but overall blood pressure ≤ 180/120 mmHg). Patients will be provided with a study overview and blood pressure measurement guide that will outline how to set up the monitor and take an accurate measurement, as well as the standard insert for how to use the home monitor and its associated smartphone application. Blood pressure readings will be electronically transmitted to Evidation Health via an Application Program Interface (API) with the blood pressure monitor manufacturer. Blood pressure will be calculated as the average of two measurements that are taken five minutes apart. Once their blood pressure readings have been confirmed as being elevated, patients will undergo randomization in a 1:1 ratio to intervention or control using simple randomization through a random number generated at the time of study enrollment.

Analyses will be performed by an intent-to-treat basis, where subjects will be analyzed in the groups they are assigned to during randomization. We will use linear regression to assess the impact of Medisafe on the study's two primary outcomes (change in systolic blood pressure and self-reported adherence) between the two study groups, three months after randomization.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Medication Adherence Improvement Support App For Engagement - Blood Pressure
Study Start Date : April 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Participants randomized to this arm will not receive the intervention.
Experimental: Intervention
Participants randomized to this arm will receive the intervention, Medisafe, a smartphone application.
 Other: Medisafe
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in systolic blood pressure [ Time Frame: Three months after randomization ]
  2. Self-reported medication adherence [ Time Frame: Three months after randomization ]

Secondary Outcome Measures :
  1. Change in number of subjects who have well controlled blood pressure [ Time Frame: Three months after randomization ]
    Well controlled blood pressure <140/90 mmHg


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727543


Locations
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United States, California
Evidation Health
Menlo Park, California, United States, 94025
Sponsors and Collaborators
Brigham and Women's Hospital
Medisafe, Inc.
Evidation Health
Investigators
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Principal Investigator: Niteesh K Choudhry, MD, PhD Center for Healthcare Delivery Sciences, Brigham and Women's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Niteesh K. Choudhry, MD, PhD, Associate Professor, Harvard Medical School and Executive Director, Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02727543    
Other Study ID Numbers: Pro00015278
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital:
Hypertension
mHealth
Medication Non-adherence
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases