The ELFIE-HYPERTENSION

NCT06242483 | Active Not Recruiting

• 1 other identifier: ELFIE
• Study Type: interventional
• Target: 930
• Locations: 2 countries
• Sites: 16

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.

Conditions

Hypertension

Keywords

Blood pressure; Digital health intervention

Outcome Measures

Primary Outcomes (1)

• Office systolic blood pressure (SBP)

  Mean systolic blood pressure, calculated as the average of the second and third readings obtained from three consecutive measurements.

  6-months

Secondary Outcomes (12)

• Percentage (%) of participants achieving office SBP < 140mmHg

  6-months

• Percentage (%) of participants achieving office SBP < 130mmHg

  6-months

• Office diastolic blood pressure (DBP)

  6-months

• Percentage (%) participants achieving DBP < 90mmHg

  6-months

• Percentage (%) participants achieving DBP < 80mmHg

  6-months

Other Outcomes (23)

• Duration of app use

  6-months

• Frequency of app use

  6-months

• Mean duration (minutes) of login sessions

  6-months

Study Arms (2)

Usual care group

NO INTERVENTION

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

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.

Other: Elfie Solution

Interventions

Elfie Solution OTHER

The Elfie solution was designed to improve knowledge, adherence, and the quality of care for patients with cardiovascular diseases. The Elfie solution comprises a mobile phone app with the following features related to hypertension: 1. Personalized monitoring plan based on health conditions to guide frequency of monitoring of blood pressure, weight, and step count 2. Digital pillbox with daily medication-taking reminders and refill reminders 3. Clinical measurements graphs for BP, weight, medical adherence and step count 4. Newsfeed with short videos and texts related to cardiovascular diseases 5. Digital coach - Artificial intelligence technology that provides information via a chatbox as well as feedback information via personalized videos. This feature does not provide medical advice. 6. Connection with a health app or wearable for step count 7. Possibility of family peer support 8. Gamification through the Elfie rewards scoring system

Digital health intervention group (Elfie solution)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Elfie Pte. Ltd.: collaborator

Study Sites (16)

Hosp. Universitário UFG

Goiânia, Goiás, Brazil

Location

Hospital Municipal Aparecida de Goiânia

Goiânia, Goiás, Brazil

Location

NF. Pacheco Cardiologia Humanizada

Belém, Pará, Brazil

Location

Rede AME Saúde

Recife, Pernambuco, Brazil

Location

Hospital Universitário Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Clínica do Coração - JMF

Aracaju, Sergipe, Brazil

Location

Hospital Universitário São Francisco na Providência de Deus

Bragança Paulista, São Paulo, Brazil

Location

Centro de Pesquisa Clínica de Guarulhos

Guarulhos, São Paulo, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652-900, Brazil

Location

CETRUS - Diagnostica LTDA

São Paulo, São Paulo, Brazil

Location

Elizabeth Do Espirito Santo Eireli

Votuporanga, São Paulo, Brazil

Location

354 Military Hospital

Hanoi, Vietnam

Location

National Geriatric Hospital

Hanoi, Vietnam

Location

District 4 Hospital

Ho Chi Minh City, Vietnam

Location

Gia Dinh hospital

Ho Chi Minh City, Vietnam

Location

Nguyen Tri Phuong Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

• Martins E, Tavares CAM, Favaro L, Monfardini F, Mourad JJ, Khunti K, Savarese G, Berwanger O, Santo K. Rationale and design of a pragmatic randomized clinical trial assessing a smartphone-based digital health intervention in hypertension: The ELFIE-HYPERTENSION trial. Am Heart J. 2026 Feb 10;297:107380. doi: 10.1016/j.ahj.2026.107380. Online ahead of print.

  PMID: 41679569 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Karla Santo, MD, Phd

  karla.santo@einstein.br

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be instructed not to mention their allocated group to the outcome assessor until the end of the follow-up visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 5, 2024
• Study Start: June 14, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (11); VN (5)