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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Elfie Solution

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 Type: Interventional
• Enrollment (Actual): 930
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Goiás
    • Goiânia, Goiás, Brazil
      • Hosp. Universitário UFG
    • Goiânia, Goiás, Brazil
      • Hospital Municipal Aparecida de Goiânia
  • Pará
    • Belém, Pará, Brazil
      • NF. Pacheco Cardiologia Humanizada
  • Pernambuco
    • Recife, Pernambuco, Brazil
      • Rede AME SAÚDE
  • Rio de Janeiro
    • Rio de Janeiro, Rio de Janeiro, Brazil
      • Hospital Universitário Pedro Ernesto
  • Sergipe
    • Aracaju, Sergipe, Brazil
      • Clínica do Coração - JMF
  • São Paulo
    • Bragança Paulista, São Paulo, Brazil
      • Hospital Universitário São Francisco na Providência de Deus
    • Guarulhos, São Paulo, Brazil
      • Centro de Pesquisa Clínica de Guarulhos
    • São Paulo, São Paulo, Brazil, 05652-900
      • Hospital Israelita Albert Einstein
    • São Paulo, São Paulo, Brazil
      • CETRUS - Diagnostica LTDA
    • Votuporanga, São Paulo, Brazil
      • Elizabeth Do Espirito Santo Eireli
• Vietnam
  • Hanoi, Vietnam
    • National Geriatric Hospital
  • Hanoi, Vietnam
    • 354 Military Hospital
  • Ho Chi Minh City, Vietnam
    • Nguyen Tri Phuong Hospital
  • Ho Chi Minh City, Vietnam
    • District 4 Hospital
  • Ho Chi Minh City, Vietnam
    • Gia Dinh hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care group; 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.
Experimental: Digital health intervention group (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.	Other: Elfie Solution; 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: Personalized monitoring plan based on health conditions to guide frequency of monitoring of blood pressure, weight, and step count; Digital pillbox with daily medication-taking reminders and refill reminders; Clinical measurements graphs for BP, weight, medical adherence and step count; Newsfeed with short videos and texts related to cardiovascular diseases; 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.; Connection with a health app or wearable for step count; Possibility of family peer support; Gamification through the Elfie rewards scoring system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage (%) of participants achieving office SBP < 140mmHg	Percentage (%) of participants achieving office SBP < 140mmHg	6-months
Percentage (%) participants achieving DBP < 90mmHg	Percentage (%) participants achieving DBP < 90mmHg	6-months
Body mass index	Mean body mass index	6-months
Quality of life measured by the SF-12 questionnaire	SF-12 questionnaire	6-months
CV-related unscheduled visits to the doctor's office or emergency room	Number of unscheduled visits	6-months
Percentage (%) of participants achieving office SBP < 130mmHg	Percentage (%) of participants achieving office SBP < 130mmHg	6-months
Percentage (%) participants achieving DBP < 80mmHg	Percentage (%) participants achieving DBP < 80mmHg	6-months
Adherence to anti-hypertensive medication measured by the 8-item Morisky Medication	8-item Morisky Medication Adherence Scale (MMAS)	6-months
Level of hypertension knowledge measured by the Hypertension Knowledge-level scale	Hypertension Knowledge-level scale (HK-LS)	6-months
Level of hypertension-related self-care measured by the Self-care of Hypertension	Self-care of Hypertension Inventory (SC-HI)	6-months
Office diastolic blood pressure (DBP)	Mean diastolic blood pressure, calculated as the average of the second and third readings obtained from three consecutive measurements.	6-months
Anti-hypertensive treatment intensification	Any anti-hypertensive treatment intensification (increase in dose or number of agents)	6-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of app use	Mean time between first and last logins in the app during study period	6-months
Frequency of app use	Mean number logins in the app	6-months
Mean duration (minutes) of login sessions	Mean duration (minutes) of login sessions	6-months
% intervention participants who entered at least 1 blood pressure measurement in the app	% intervention participants who entered at least 1 blood pressure measurement in the app	6-months
Mean number blood pressure measurements entered in the app	Mean number blood pressure measurements entered in the app	6-months
Mean systolic blood pressure entered in the app	Mean systolic blood pressure entered in the app (both manually entered and automatically transmitted via Bluetooth)	6-months
Mean diastolic blood pressure entered in the app	Mean diastolic blood pressure entered in the app (both manually entered and automatically transmitted via Bluetooth)	6-months
% intervention participants who entered at least 1 medication (any medication) in the app	% intervention participants who entered at least 1 medication (any medication) in the app	6-months
% intervention participants who entered at least 1 anti-hypertensive medication in the app	% intervention participants who entered at least 1 anti-hypertensive medication in the app	6-months
Mean number medications entered in the app	Mean number medications entered in the app	6-months
Types of medications entered in the app	Anti-hypertensive, anti-diabetic, lipid-lowering medications	6-months
% adherence to medications in the app	% adherence to medications in the app	6-months
% intervention participants who entered at least 1 weight measurement in the app	% intervention participants who entered at least 1 weight measurement in the app	6-months
Mean number weight measurements entered in the app	Mean number weight measurements entered in the app	6-months
Mean weight entered in the app	Mean weight entered in the app	6-months
% intervention participants who connect the Elfie app with a health app for step count	% intervention participants who connect the Elfie app with a health app for step count	6-months
Mean number daily steps	Mean number daily steps	6-months
% intervention participants who used the digital coach feature at least once	% intervention participants who used the digital coach feature at least once (both the chatbox and the personalized videos)	6-months
Mean number of times the digital coach feature was used	Mean number of times the digital coach feature was used (both the chatbox and the personalized videos)	6-months
% intervention participants who used the rewards feature	% intervention participants who used the rewards feature	6-months
Mean number of times the rewards feature was used	Mean number of times the rewards feature was used	6-months
% intervention participants who used the family support feature	% intervention participants who used the family support feature	6-months
% intervention participants who used monitoring features for other diseases (diabetes, dyslipidemia, angina)	% intervention participants who used monitoring features for other diseases (diabetes, dyslipidemia, angina)	6-months

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: Elfie Pte. Ltd.
• Investigators: Principal Investigator: Karla Santo, MD, Phd, karla.santo@einstein.br

Publications and helpful links

General Publications

• 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 Jul;297:107380. doi: 10.1016/j.ahj.2026.107380. Epub 2026 Feb 10.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2024
• Primary Completion (Actual): April 8, 2026
• Study Completion (Actual): April 8, 2026

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Blood pressure; Digital health intervention
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: ELFIE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No