The ELFIE-HYPERTENSION

Last updated: April 4, 2025
Sponsor: Hospital Israelita Albert Einstein
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stress

Circulation Disorders

Vascular Diseases

Treatment

Elfie Solution

Clinical Study ID

NCT06242483
ELFIE
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 screeningvisit

  • Patients in whom medication adherence needs to be improved according to thehealthcare provider clinical judgment

  • Use of at least 1 anti-hypertensive medication

  • Ownership of an active smartphone with operational system iOS (version 13.0 orlater) or Android (version 8.0 or later) with access to the internet on 3G, 4G or 5G

  • Ability to use a smartphone app

Exclusion

Exclusion Criteria:

  • Refusal to provide written informed consent

  • Current use of a health app with the aim to improve medication adherence and bloodpressure 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

Study Design

Total Participants: 930
Treatment Group(s): 1
Primary Treatment: Elfie Solution
Phase:
Study Start date:
June 14, 2024
Estimated Completion Date:
October 31, 2025

Study 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

Connect with a study center

  • Hospital Municipal Aparecida de Goiânia

    Goiânia, Goias
    Brazil

    Site Not Available

  • Hosp. Universitário UFG

    Goiânia, Goiás
    Brazil

    Site Not Available

  • NF. Pacheco Cardiologia Humanizada

    Belém, Pará
    Brazil

    Site Not Available

  • Rede AME Saúde

    Recife, Pernambuco
    Brazil

    Site Not Available

  • Clínica do Coração - JMF

    Aracaju, Sergipe
    Brazil

    Site Not Available

  • Hospital Universitário São Francisco na Providência de Deus

    Bragança Paulista, São Paulo
    Brazil

    Site Not Available

  • Centro de Pesquisa Clínica de Guarulhos

    Guarulhos, São Paulo
    Brazil

    Site Not Available

  • Elizabeth Do Espirito Santo Eireli

    Votuporanga, São Paulo
    Brazil

    Site Not Available

  • Hospital Universitário Pedro Ernesto

    Rio De Janeiro,
    Brazil

    Site Not Available

  • CETRUS - Diagnostica LTDA

    São Paulo,
    Brazil

    Site Not Available

  • Hospital Israelita Albert Einstein

    São Paulo, 05652-900
    Brazil

    Site Not Available

  • 354 Military Hospital

    Hanoi,
    Vietnam

    Site Not Available

  • National Geriatric Hospital

    Hanoi,
    Vietnam

    Site Not Available

  • Gia Dinh hospital

    Ho Chi Minh,
    Vietnam

    Site Not Available

  • District 4 Hospital

    Ho Chi Minh City,
    Vietnam

    Site Not Available

  • Nguyen Tri Phuong Hospital

    Ho Chi Minh City,
    Vietnam

    Site Not Available

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