The ELFIE-HYPERTENSION

The ELFIE-HYPERTENSION Randomized Clinical Trial

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 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

Inclusion Criteria:

• 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) 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

Exclusion Criteria:

• 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