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| Name | Class |
|---|---|
| Medisafe, Inc. | INDUSTRY |
| Evidation Health | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medisafe | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic blood pressure | Three months after randomization | |
| Self-reported medication adherence | Three months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of subjects who have well controlled blood pressure | Well controlled blood pressure <140/90 mmHg | Three months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niteesh K Choudhry, MD, PhD | Center for Healthcare Delivery Sciences, Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidation Health | Menlo Park | California | 94025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29710289 | Derived | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |