Medication Adherence Improvement Support App For Engagement - Blood Pressure
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 1/19/2017 |
| Start Date: | April 2016 |
| End Date: | January 2017 |
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.
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.
(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.
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
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