Last updated 2 months ago
The ELFIE-HYPERTENSION
866 patients around the world
Available in Brazil
The ELFIE-HYPERTENSION randomized clinical trial is an academic-led, collaborative,
pragmatic, randomized, open-label, parallel arm, multicenter, trial evaluating whether a
digital health intervention based on the Elfie solution compared with usual care will
reduce systolic blood pressure in individuals with hypertension. The study will also
evaluate whether this digital health intervention compared to usual care will improve
diastolic blood pressure, adherence to anti-hypertensive medication, anti-hypertensive
treatment intensification, body mass index, hypertension knowledge, self-care, quality of
life, and the need for unscheduled cardiovascular-related medical assessment.
The hypothesis is that the Elfie solution will improve blood pressure control in
individuals with hypertension
Hospital Israelita Albert Einstein
1Research sites
866Patients around the world
This study is for people with
Arterial hypertension
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- Age ≥ 18 years and ≤ 75 years.Male and female patients.Hypertension diagnosis based on the local guidelines criteria.Uncontrolled blood pressure (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) on the screening visit.Patients in whom medication adherence needs to be improved according to the healthcare provider clinical judgment.Use of at least 1 anti-hypertensive medication.Ownership of an active smartphone with operational system iOS (version 13.0 or later) or Android (version 8.0 or later) with access to the internet on 3G, 4G or 5G.Ability to use a smartphone app.
- Refusal to provide written informed consent.Current use of a health app with the aim to improve medication adherence and blood pressure control.Illiteracy to read in the local language.Known cognitive decline, dementia, or diagnosis of severe psychiatric conditions (depression, schizophrenia, bipolar disorder).Known use of illicit drugs or alcoholism.Current participation in a cardiovascular randomized clinical trial.Life expectancy < 1 year.
Sites
Hospital Israelita Albert Einstein - Fortaleza, Ceara
StudyELFIE-HYPERTENSION
SponsorHospital Israelita Albert Einstein
Conditions
Arterial hypertension
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06242483
