The ELFIE-HYPERTENSION

Not Applicable

Active, not recruiting

• Conditions: Hypertension
• Interventions: Other: Elfie Solution

• Registration Number: NCT06242483
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-05
• Study Start: 2024-06-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 930

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital health intervention group (Elfie solution)	Elfie Solution	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.

Primary Outcome Measures

Name	Time	Method
Office systolic blood pressure (SBP)	6-months	Mean systolic blood pressure in the office

Secondary Outcome Measures

Name	Time	Method
Anti-hypertensive treatment intensification	6-months	Intensification of anti-hypertensive treatment
Quality of life measured by the SF-12 questionnaire	6-months	SF-12 questionnaire
Percentage (%) participants achieving DBP < 90mmHg	6-months	Percentage (%) participants achieving DBP \< 90mmHg
Percentage (%) of participants achieving office SBP < 130mmHg	6-months	Percentage (%) of participants achieving office SBP \< 130mmHg
Level of hypertension knowledge measured by the Hypertension Knowledge-level scale	6-months	Hypertension Knowledge-level scale (HK-LS)
Office diastolic blood pressure (DBP)	6-months	Mean diastolic blood pressure in the office
Body mass index	6-months	Mean body mass index
Adherence to anti-hypertensive medication measured by the 8-item Morisky Medication	6-months	8-item Morisky Medication Adherence Scale (MMAS)
Percentage (%) of participants achieving office SBP < 140mmHg	6-months	Percentage (%) of participants achieving office SBP \< 140mmHg
Percentage (%) participants achieving DBP < 80mmHg	6-months	Percentage (%) participants achieving DBP \< 80mmHg
Level of hypertension-related self-care measured by the Self-care of Hypertension	6-months	Self-care of Hypertension Inventory (SC-HI)
CV-related unscheduled visits to the doctor's office or emergency room	6-months	Number of unscheduled visits

Trial Locations

Locations (16)

Hospital Municipal Aparecida de Goiânia; 🇧🇷 Goiânia, Goias, Brazil

Centro de Pesquisa Clínica de Guarulhos; 🇧🇷 Guarulhos, São Paulo, Brazil

CETRUS - Diagnostica LTDA; 🇧🇷 São Paulo, Brazil

Nguyen Tri Phuong Hospital; 🇻🇳 Ho Chi Minh City, Vietnam

Gia Dinh hospital; 🇻🇳 Ho Chi Minh, Vietnam

Hosp. Universitário UFG; 🇧🇷 Goiânia, Goiás, Brazil

NF. Pacheco Cardiologia Humanizada; 🇧🇷 Belém, Pará, Brazil

Rede AME Saúde; 🇧🇷 Recife, Pernambuco, Brazil

Clínica do Coração - JMF; 🇧🇷 Aracaju, Sergipe, Brazil

Hospital Universitário São Francisco na Providência de Deus; 🇧🇷 Bragança Paulista, São Paulo, Brazil

Elizabeth Do Espirito Santo Eireli; 🇧🇷 Votuporanga, São Paulo, Brazil

Hospital Universitário Pedro Ernesto; 🇧🇷 Rio De Janeiro, Brazil

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Brazil

354 Military Hospital; 🇻🇳 Hanoi, Vietnam

National Geriatric Hospital; 🇻🇳 Hanoi, Vietnam

District 4 Hospital; 🇻🇳 Ho Chi Minh City, Vietnam