Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06242483
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-01-29
Brief Title:
The ELFIE-HYPERTENSION
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
The ELFIE-HYPERTENSION Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
The hypothesis is that the Elfie solution will improve blood pressure control in individuals with hypertension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None