Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06091176
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-10-13
Brief Title:
Assessment of Efficacy and Safety of Amicomed for the Management of Essential Hypertension
Sponsor:
Newel Health SRL
Organization:
Newel Health SRL
Study Overview
Official Title:
A Multicenter Randomized Parallel-Group Single-Blind Study to Compare the Efficacy and Safety of Amicomed for the Management of Essential Hypertension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
This is a multicenter randomized single-blind parallel-group study to evaluate the efficacy and safety of Amicomed compared with Usual Care UC over a 24-week treatment period in subjects with essential hypertension mean home based systolic blood pressure SBP 140 andor diastolic blood pressure DBP 90 mm Hg on Day 1
Detailed Description:
Amicomed is a Digital therapeutics service and program for BP management and reduction The key features of Amicomed include
1 an automatic expert system based finite-machine AI algorithm for assessing the evolution of blood pressure levels
2 an automatic expert system based finite-machine AI algorithm for generating and delivering a detailed lifestyle program dietary and physical activity starting from the general lifestyle suggestions of the hypertension and cardiovascular prevention guidelines and producing a truly personalized program
3 a behavioral strategy embedded into the app to increase adherence and persistence into the program
The Amicomed Digital Therapeutics Service and App for hypertension management and intervention has been shown to significantly improve BP levels in case-control studies These initial results demonstrated a 5mmHg systolic BP reduction across all Amicomed subscribers and 79 mmHg systolic BP reduction in subject with stage 1 hypertension Comparable reduction of diastolic BP was also achieved
The aim of this study is to investigate the long-term efficacy of the Amicomed Digital Therapeutics Program compared to Usual Care in reducing Systolic and Diastolic Blood Pressure in subjects with primary hypertension
1 an automatic expert system based finite-machine AI algorithm for assessing the evolution of blood pressure levels
2 an automatic expert system based finite-machine AI algorithm for generating and delivering a detailed lifestyle program dietary and physical activity starting from the general lifestyle suggestions of the hypertension and cardiovascular prevention guidelines and producing a truly personalized program
3 a behavioral strategy embedded into the app to increase adherence and persistence into the program
The Amicomed Digital Therapeutics Service and App for hypertension management and intervention has been shown to significantly improve BP levels in case-control studies These initial results demonstrated a 5mmHg systolic BP reduction across all Amicomed subscribers and 79 mmHg systolic BP reduction in subject with stage 1 hypertension Comparable reduction of diastolic BP was also achieved
The aim of this study is to investigate the long-term efficacy of the Amicomed Digital Therapeutics Program compared to Usual Care in reducing Systolic and Diastolic Blood Pressure in subjects with primary 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