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NCT06242483 Clinical Trial

The ELFIE-HYPERTENSION

Hypertension Clinical Trial

Official title:
The ELFIE-HYPERTENSION Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06242483
Other study ID # ELFIE
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date July 1, 2025

Study information
Verified date January 2024
Source Hospital Israelita Albert Einstein
Contact Eduardo B Martins, MD, Phd
Phone 11-995933949
Email eduardo.bello@einstein.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 hypertension.

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 866
Est. completion date July 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Brazil Hospital Israelita Albert Einstein São Paulo

Sponsors (2)
Lead Sponsor Collaborator
Hospital Israelita Albert Einstein Elfie Pte. Ltd.

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Other Duration of app use Mean time between first and last logins in the app during study period 6-months
Other Frequency of app use Mean number logins in the app 6-months
Other Mean duration (minutes) of login sessions Mean duration (minutes) of login sessions 6-months
Other % 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
Other Mean number blood pressure measurements entered in the app Mean number blood pressure measurements entered in the app 6-months
Other 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
Other 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
Other % 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
Other % 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
Other Mean number medications entered in the app Mean number medications entered in the app 6-months
Other Types of medications entered in the app Anti-hypertensive, anti-diabetic, lipid-lowering medications 6-months
Other % adherence to medications in the app % adherence to medications in the app 6-months
Other % 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
Other Mean number weight measurements entered in the app Mean number weight measurements entered in the app 6-months
Other Mean weight entered in the app Mean weight entered in the app 6-months
Other % 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
Other Mean number daily steps Mean number daily steps 6-months
Other % 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
Other 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
Other % intervention participants who used the rewards feature % intervention participants who used the rewards feature 6-months
Other Mean number of times the rewards feature was used Mean number of times the rewards feature was used 6-months
Other % intervention participants who used the family support feature % intervention participants who used the family support feature 6-months
Other % 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
Primary Office systolic blood pressure (SBP) Mean systolic blood pressure in the office 6-months
Secondary Percentage (%) of participants achieving office SBP < 140mmHg Percentage (%) of participants achieving office SBP < 140mmHg 6-months
Secondary Percentage (%) of participants achieving office SBP < 130mmHg Percentage (%) of participants achieving office SBP < 130mmHg 6-months
Secondary Office diastolic blood pressure (DBP) Mean diastolic blood pressure in the office 6-months
Secondary Percentage (%) participants achieving DBP < 90mmHg Percentage (%) participants achieving DBP < 90mmHg 6-months
Secondary Percentage (%) participants achieving DBP < 80mmHg Percentage (%) participants achieving DBP < 80mmHg 6-months
Secondary Anti-hypertensive treatment intensification Intensification of anti-hypertensive treatment 6-months
Secondary Body mass index Mean body mass index 6-months
Secondary Adherence to anti-hypertensive medication measured by the 8-item Morisky Medication 8-item Morisky Medication Adherence Scale (MMAS) 6-months
Secondary Level of hypertension knowledge measured by the Hypertension Knowledge-level scale Hypertension Knowledge-level scale (HK-LS) 6-months
Secondary Level of hypertension-related self-care measured by the Self-care of Hypertension Self-care of Hypertension Inventory (SC-HI) 6-months
Secondary Quality of life measured by the SF-12 questionnaire SF-12 questionnaire 6-months
Secondary CV-related unscheduled visits to the doctor's office or emergency room Number of unscheduled visits 6-months
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