The ELFIE-HYPERTENSION

Hospital Israelita Albert Einstein930 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

930

Conditions

Hypertension

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (16)

Hosp. Universitário UFG

Goiânia, Goiás, Brazil

Hospital Municipal Aparecida de Goiânia

Goiânia, Goiás, Brazil

NF. Pacheco Cardiologia Humanizada

Outcomes

Primary Outcomes

Office systolic blood pressure (SBP)

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

Time frame: 6-months

Secondary Outcomes

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

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

Time frame: 6-months

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

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

Time frame: 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.

Time frame: 6-months

Percentage (%) participants achieving DBP < 90mmHg

Percentage (%) participants achieving DBP \< 90mmHg

Time frame: 6-months

Percentage (%) participants achieving DBP < 80mmHg

Percentage (%) participants achieving DBP \< 80mmHg

Time frame: 6-months

Anti-hypertensive treatment intensification

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

Time frame: 6-months

Body mass index

Mean body mass index

Data from ClinicalTrials.gov

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