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| Name | Class |
|---|---|
| Elfie Pte. Ltd. | UNKNOWN |
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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) of participants achieving office SBP < 140mmHg | Percentage (%) of participants achieving office SBP < 140mmHg | 6-months |
| Percentage (%) of participants achieving office SBP < 130mmHg |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karla Santo, MD, Phd | karla.santo@einstein.br | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hosp. Universitário UFG | Goiânia | Goiás | Brazil | |||
| Hospital Municipal Aparecida de Goiânia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41679569 | Derived | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Participants will be instructed not to mention their allocated group to the outcome assessor until the end of the follow-up visit.
|
Percentage (%) of participants achieving office SBP < 130mmHg
| 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 |
| Percentage (%) participants achieving DBP < 90mmHg | Percentage (%) participants achieving DBP < 90mmHg | 6-months |
| Percentage (%) participants achieving DBP < 80mmHg | Percentage (%) participants achieving DBP < 80mmHg | 6-months |
| Anti-hypertensive treatment intensification | Any anti-hypertensive treatment intensification (increase in dose or number of agents) | 6-months |
| Body mass index | Mean body mass index | 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 |
| 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 |
| 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 |
| Goiânia |
| Goiás |
| Brazil |
| NF. Pacheco Cardiologia Humanizada | Belém | Pará | Brazil |
| Rede AME Saúde | Recife | Pernambuco | Brazil |
| Hospital Universitário Pedro Ernesto | Rio de Janeiro | Rio de Janeiro | Brazil |
| Clínica do Coração - JMF | Aracaju | Sergipe | Brazil |
| Hospital Universitário São Francisco na Providência de Deus | Bragança Paulista | São Paulo | Brazil |
| Centro de Pesquisa Clínica de Guarulhos | Guarulhos | São Paulo | Brazil |
| Hospital Israelita Albert Einstein | São Paulo | São Paulo | 05652-900 | Brazil |
| CETRUS - Diagnostica LTDA | São Paulo | São Paulo | Brazil |
| Elizabeth Do Espirito Santo Eireli | Votuporanga | São Paulo | Brazil |
| 354 Military Hospital | Hanoi | Vietnam |
| National Geriatric Hospital | Hanoi | Vietnam |
| District 4 Hospital | Ho Chi Minh City | Vietnam |
| Gia Dinh hospital | Ho Chi Minh City | Vietnam |
| Nguyen Tri Phuong Hospital | Ho Chi Minh City | Vietnam |