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HypertensionNCT06242483

The ELFIE-HYPERTENSION

A study testing Elfie Solution in people with Hypertension, run by Hospital Israelita Albert Einstein at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertension
What is being tested?
Elfie Solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
930 participants
Where
16 sitesin 2 countries
Study dates
14 Jun 2024to 8 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

Brazil11 sites

  • Clínica do Coração - JMF

    Aracaju, Sergipe

  • NF. Pacheco Cardiologia Humanizada

    Belém, Pará

  • Hospital Universitário São Francisco na Providência de Deus

    Bragança Paulista, São Paulo

  • Hosp. Universitário UFG

    Goiânia, Goiás

  • Hospital Municipal Aparecida de Goiânia

    Goiânia, Goiás

  • Centro de Pesquisa Clínica de Guarulhos

    Guarulhos, São Paulo

  • Rede AME Saúde

    Recife, Pernambuco

  • Hospital Universitário Pedro Ernesto

    Rio de Janeiro, Rio de Janeiro

  • Hospital Israelita Albert Einstein

    São Paulo, São Paulo, 05652-900

  • CETRUS - Diagnostica LTDA

    São Paulo, São Paulo

  • Elizabeth Do Espirito Santo Eireli

    Votuporanga, São Paulo

Other trials in Brazil

Vietnam5 sites

  • 354 Military Hospital

    Hanoi

  • National Geriatric Hospital

    Hanoi

  • District 4 Hospital

    Ho Chi Minh City

  • Gia Dinh hospital

    Ho Chi Minh City

  • Nguyen Tri Phuong Hospital

    Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: 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.

Read the 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

Conditions
Hypertension
Being tested
Elfie Solution
Keywords
Blood pressure, Digital health intervention
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elfie SolutionOther

    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
Study groups in NCT06242483
Study groupRoleWhat they receive
Usual care groupNo interventionPatients 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)ExperimentalPatients 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.
Receives: Other: Elfie Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6-months

Secondary outcomes (12)

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

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

    Measured: 6-months

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

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

    Measured: 6-months

  3. Office diastolic blood pressure (DBP)

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

    Measured: 6-months

  4. Percentage (%) participants achieving DBP < 90mmHg

    Percentage (%) participants achieving DBP < 90mmHg

    Measured: 6-months

  5. Percentage (%) participants achieving DBP < 80mmHg

    Percentage (%) participants achieving DBP < 80mmHg

    Measured: 6-months

  6. Anti-hypertensive treatment intensification

    Any anti-hypertensive treatment intensification (increase in dose or number of agents)

    Measured: 6-months

  7. Body mass index

    Mean body mass index

    Measured: 6-months

  8. Adherence to anti-hypertensive medication measured by the 8-item Morisky Medication

    8-item Morisky Medication Adherence Scale (MMAS)

    Measured: 6-months

  9. Level of hypertension knowledge measured by the Hypertension Knowledge-level scale

    Hypertension Knowledge-level scale (HK-LS)

    Measured: 6-months

  10. Level of hypertension-related self-care measured by the Self-care of Hypertension

    Self-care of Hypertension Inventory (SC-HI)

    Measured: 6-months

  11. Quality of life measured by the SF-12 questionnaire

    SF-12 questionnaire

    Measured: 6-months

  12. CV-related unscheduled visits to the doctor's office or emergency room

    Number of unscheduled visits

    Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2024
  2. Study start14 Jun 2024
  3. Primary completion8 Apr 2026
  4. Study completion8 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
930 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06242483
Sponsor's protocol ID
ELFIE
Status last verified
Mar 2026
First submitted
29 Jan 2024
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 41679569

Questions about this trial

What is this clinical trial studying?

A study testing Elfie Solution in people with Hypertension, run by Hospital Israelita Albert Einstein at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Brazil, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Office systolic blood pressure (SBP) (time frame: 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06242483, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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