Clinical trial NCT06242483: The ELFIE-HYPERTENSION
Official title: The ELFIE-HYPERTENSION Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Blood pressure
Digital health intervention
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Elfie Pte. Ltd.
First posted: 2024-02-05
Enrollment: 930
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Office systolic blood pressure (SBP)
timeFrame: 6-months
Secondary outcomes:
measure: Percentage (%) of participants achieving office SBP < 140mmHg
timeFrame: 6-months
measure: Percentage (%) of participants achieving office SBP < 130mmHg
timeFrame: 6-months
measure: Office diastolic blood pressure (DBP)
timeFrame: 6-months
measure: Percentage (%) participants achieving DBP < 90mmHg
timeFrame: 6-months
measure: Percentage (%) participants achieving DBP < 80mmHg
timeFrame: 6-months
measure: Anti-hypertensive treatment intensification
timeFrame: 6-months
measure: Body mass index
timeFrame: 6-months
measure: Adherence to anti-hypertensive medication measured by the 8-item Morisky Medication
timeFrame: 6-months
measure: Level of hypertension knowledge measured by the Hypertension Knowledge-level scale
timeFrame: 6-months
measure: Level of hypertension-related self-care measured by the Self-care of Hypertension
timeFrame: 6-months
measure: Quality of life measured by the SF-12 questionnaire
timeFrame: 6-months
measure: CV-related unscheduled visits to the doctor's office or emergency room
timeFrame: 6-months
Other outcomes:
measure: Duration of app use
timeFrame: 6-months
measure: Frequency of app use
timeFrame: 6-months
measure: Mean duration (minutes) of login sessions
timeFrame: 6-months
measure: % intervention participants who entered at least 1 blood pressure measurement in the app
timeFrame: 6-months
measure: Mean number blood pressure measurements entered in the app
timeFrame: 6-months
measure: Mean systolic blood pressure entered in the app
timeFrame: 6-months
measure: Mean diastolic blood pressure entered in the app
timeFrame: 6-months
measure: % intervention participants who entered at least 1 medication (any medication) in the app
timeFrame: 6-months
measure: % intervention participants who entered at least 1 anti-hypertensive medication in the app
timeFrame: 6-months
measure: Mean number medications entered in the app
timeFrame: 6-months
measure: Types of medications entered in the app
timeFrame: 6-months
measure: % adherence to medications in the app
timeFrame: 6-months
measure: % intervention participants who entered at least 1 weight measurement in the app
timeFrame: 6-months
measure: Mean number weight measurements entered in the app
timeFrame: 6-months
measure: Mean weight entered in the app
timeFrame: 6-months
measure: % intervention participants who connect the Elfie app with a health app for step count
timeFrame: 6-months
measure: Mean number daily steps
timeFrame: 6-months
measure: % intervention participants who used the digital coach feature at least once
timeFrame: 6-months
measure: Mean number of times the digital coach feature was used
timeFrame: 6-months
measure: % intervention participants who used the rewards feature
timeFrame: 6-months
measure: Mean number of times the rewards feature was used
timeFrame: 6-months
measure: % intervention participants who used the family support feature
timeFrame: 6-months
measure: % intervention participants who used monitoring features for other diseases (diabetes, dyslipidemia, angina)
timeFrame: 6-months
Locations:
city: Goiânia
country: Brazil
facility: Hospital Municipal Aparecida de Goiânia
state: Goias
city: Goiânia
country: Brazil
facility: Hosp. Universitário UFG
state: Goiás
city: Belém
country: Brazil
facility: NF. Pacheco Cardiologia Humanizada
state: Pará
city: Recife
country: Brazil
facility: Rede AME Saúde
state: Pernambuco
city: Aracaju
country: Brazil
facility: Clínica do Coração - JMF
state: Sergipe
city: Bragança Paulista
country: Brazil
facility: Hospital Universitário São Francisco na Providência de Deus
state: São Paulo
city: Guarulhos
country: Brazil
facility: Centro de Pesquisa Clínica de Guarulhos
state: São Paulo
city: Votuporanga
country: Brazil
facility: Elizabeth Do Espirito Santo Eireli
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: Hospital Universitário Pedro Ernesto
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: São Paulo
country: Brazil
facility: CETRUS - Diagnostica LTDA
city: Hanoi
country: Vietnam
facility: 354 Military Hospital
city: Hanoi
country: Vietnam
facility: National Geriatric Hospital
city: Ho Chi Minh City
country: Vietnam
facility: District 4 Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Nguyen Tri Phuong Hospital
city: Ho Chi Minh
country: Vietnam
facility: Gia Dinh hospital
Study officials:
affiliation: karla.santo@einstein.br
name: Karla Santo, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: