Medication Adherence Improvement Support App For Engagement - Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

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.
    

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.
    

Intervention name(s): Medisafe
Intervention type(s): Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Hypertension; mHealth; Medication Non-adherence