HypertensionMedISAFE-BPNCT02727543
Medication Adherence Improvement Support App For Engagement - Blood Pressure
A study testing Medisafe in people with Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Medisafe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Medisafe
- Keywords
- Hypertension, mHealth, Medication Non-adherence
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedisafeOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Medisafe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
Measured: Three months after randomization
Self-reported medication adherence
Measured: Three months after randomization
Secondary outcomes (1)
Change in number of subjects who have well controlled blood pressure
Well controlled blood pressure <140/90 mmHg
Measured: Three months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medisafe, Inc., Evidation Health
- Responsible party
- Principal investigator, Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
- Investigators
- Niteesh K Choudhry, MD, PhD, Principal investigator, Center for Healthcare Delivery Sciences, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727543
- Sponsor's protocol ID
- Pro00015278
- Acronym
- MedISAFE-BP
- Status last verified
- Jan 2017
- First submitted
- 31 Mar 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29710289
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Adherence Improvement Support App For Engagement - Blood Pressure
- ClinicalTrials.gov ID
- NCT02727543
- Acronym / sponsor ID
- MedISAFE-BP / Pro00015278
- Conditions
- Hypertension
- Keywords
- Hypertension, mHealth, Medication Non-adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Medisafe, Inc., Evidation Health
- Study start
- Apr 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants randomized to this arm will not receive the intervention. |
| Intervention | Experimental | Other: MedisafeParticipants randomized to this arm will receive the intervention, Medisafe, a smartphone application. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedisafeMedisafe 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 | Other | Intervention |
Primary outcome
Change in systolic blood pressure
Time frame: Three months after randomization
Self-reported medication adherence
Time frame: Three months after randomization
1 secondary outcome
Change in number of subjects who have well controlled blood pressure
Time frame: Three months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Derived from this study: PubMed 29710289Morawski 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.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niteesh K Choudhry, MD, PhD principal investigator
Center for Healthcare Delivery Sciences, Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medisafe in people with Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure (time frame: Three months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02727543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.