The ELFIE-HYPERTENSION

Hospital Israelita Albert Einstein

Status: Active, not recruiting

Conditions: Hypertension

Treatments: Other: Elfie Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06242483

ELFIE

Details and patient eligibility

About

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.

Full description

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

Enrollment: 930 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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930 participants in 2 patient groups

Usual care group

No Intervention group

Description:

Patients randomized to usual care will receive standard care, in which hypertension treatment will be provided according to local practices and will not have access to the Elfie solution. Additionally, they will be requested not to access/use other mobile phone apps or participate in any kind of digital health intervention related to hypertension treatment during the trial.

Digital health intervention group (Elfie solution)

Experimental group

Description:

Patients randomized to digital health intervention group will receive standard care plus the Elfie solution. Participants randomized to the Elfie solution will be instructed to download the Elfie app and will receive training on how to register in the app and on how to use all the app features. Participants will be then instructed to use the app according to the monitoring plan created by the app for the following 6 months.

Treatment:

Other: Elfie Solution