NCT06242483

The ELFIE-HYPERTENSION

The ELFIE-HYPERTENSION Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 930 (actual)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypertension

Interventions

Type	Name	Description
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: 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

Timeline

• Start date: 2024-06-14
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2024-02-05
• Last updated: 2026-03-13

Locations

16 sites across 2 countries: Brazil, Vietnam