Medication Adherence Improvement Support App For Engagement - Blood Pressure (MedISAFE-BP)
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|ClinicalTrials.gov Identifier: NCT02727543|
Recruitment Status : Completed
First Posted : April 4, 2016
Last Update Posted : January 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Other: Medisafe||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||413 participants|
|Intervention Model:||Parallel Assignment|
|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|
No Intervention: Control
Participants randomized to this arm will not receive the intervention.
Participants randomized to this arm will receive the intervention, Medisafe, a smartphone application.
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
- Change in systolic blood pressure [ Time Frame: Three months after randomization ]
- Self-reported medication adherence [ Time Frame: Three months after randomization ]
- Change in number of subjects who have well controlled blood pressure [ Time Frame: Three months after randomization ]Well controlled blood pressure <140/90 mmHg
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
|United States, California|
|Menlo Park, California, United States, 94025|
|Principal Investigator:||Niteesh K Choudhry, MD, PhD||Center for Healthcare Delivery Sciences, Brigham and Women's Hospital|