The ELFIE-HYPERTENSION
NCT06242483 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 930
Last updated 2026-03-13
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Elfie Pte. Ltd.
collaborator UNKNOWN -
Hospital Israelita Albert Einstein
lead OTHER
Principal Investigators
-
Karla Santo, MD, Phd · [email protected]
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-14
- Primary Completion
- 2026-04-30
- Completion
- 2026-04-30
Countries
- Brazil
- Vietnam
Study Locations
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