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 and/or diastolic blood pressure DBP ≥ 90 mm Hg on Day 1).
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 7.9 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
316
This app helps users track their blood pressure readings over time with analysis and history features. It generates graphs and charts to display trends and patterns, and users can set reminders to take blood pressure readings. Additionally, the app offers personalized recommendations for lifestyle, including personalized diet plans, and physical exercise programs based on the user's information. Using cognitive-behavioral techniques and motivational levers, the app helps users overcome barriers to lifestyle changes and provides personalized feedback and coaching. It also includes a database of evidence-based strategies for behavior change, and users can receive notifications, reminders, and rewards to stay motivated.
Subjects will be provided with a white label mobile app, which allows to (1) add blood pressure measurements, (2) access the history of recorded measurements. No notification system will be implemented.
Change in Home Blood Pressure Monitoring - Systolic Blood Pressure
The primary endpoint is change from baseline to Week 12 in trough (approximately 7 days before the previous visit) Home BP SBP. Home BP is the average of all BP readings performed with a semiautomatic, validated BP monitor, for at least 3 days and preferably for 6-7 consecutive days before each clinic visit, with readings in the morning and the evening, taken in a quiet room after 5 min of rest, with the patient seated with their back and arm supported. Two measurements should be taken at each measurement session, performed 1-2 min apart. The primary endpoints will be collected using dedicated BP monitoring devices. Measurements taken for the purpose of efficacy assessment will not be reported to, nor shared or collected through the Investigational Device ID1.
Time frame: Baseline to Week 12
Change in Home Blood Pressure Monitoring - Dyastolic Blood Pressure
The primary endpoint is change from baseline to Week 12 in trough (approximately 7 days before the previous visit) Home BP SBP. Home BP is the average of all BP readings performed with a semiautomatic, validated BP monitor, for at least 3 days and preferably for 6-7 consecutive days before each clinic visit, with readings in the morning and the evening, taken in a quiet room after 5 min of rest, with the patient seated with their back and arm supported. Two measurements should be taken at each measurement session, performed 1-2 min apart. The primary endpoints will be collected using dedicated BP monitoring devices. Measurements taken for the purpose of efficacy assessment will not be reported to, nor shared or collected through the Investigational Device ID1.
Time frame: Baseline to Week 12
The change from baseline to Week 24 in trough Home BP Systolic Blood Pressure
Change from baseline to Week 24 in trough (approximately 7 days before the previous visit) Home BP SBP. Home BP is the average of all BP readings performed with a semiautomatic, validated BP monitor, for at least 3 days and preferably for 6-7 consecutive days before each clinic visit, with readings in the morning and the evening, taken in a quiet room after 5 min of rest, with the patient seated with their back and arm supported. Two measurements should be taken at each measurement session, performed 1-2 min apart. The endpoints will be collected using dedicated BP monitoring devices. Measurements taken for the purpose of efficacy assessment will not be reported to, nor shared or collected through the Investigational Device ID1.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Usual Care (UC): Subjects assigned to control group will receive care as usual care, including self-monitoring indications.
Time frame: Baseline to Week 24
The change from baseline to Week 24 in trough Home BP Diastolic Blood Pressure
Change from baseline to Week 24 in trough (approximately 7 days before the previous visit) Home BP DBP. Home BP is the average of all BP readings performed with a semiautomatic, validated BP monitor, for at least 3 days and preferably for 6-7 consecutive days before each clinic visit, with readings in the morning and the evening, taken in a quiet room after 5 min of rest, with the patient seated with their back and arm supported. Two measurements should be taken at each measurement session, performed 1-2 min apart. The endpoints will be collected using dedicated BP monitoring devices. Measurements taken for the purpose of efficacy assessment will not be reported to, nor shared or collected through the Investigational Device ID1.
Time frame: Baseline to Week 24
Percentage of responders at Week 12 Home BP SBP <140 mm Hg and/or reduction of ≥5 mm Hg from baseline.
Percentage of responders who show at Week 12 Home BP SBP \<140 mm Hg and/or a reduction of ≥5 mm Hg from baseline.
Time frame: Baseline to Week 12
Percentage of responders at Week 24 Home BP SBP <140 mm Hg and/or reduction of ≥5 mm Hg from baseline.
Percentage of responders who show at Week 24 Home BP SBP \<140 mm Hg and/or a reduction of ≥5 mm Hg from baseline.
Time frame: Baseline to Week 24
Percentage of responders at Week 12 Home BP DBP <90 mm Hg and/or reduction of ≥5 mm Hg from baseline.
Percentage of responders who show at Week 12 Home BP DBP \<90 mm Hg and/or a reduction of ≥5 mm Hg from baseline.
Time frame: Baseline to Week 12
Percentage of responders at Week 24 Home BP DBP <90 mm Hg and/or reduction of ≥5 mm Hg from baseline.
Percentage of responders who show at Week 24 Home BP DBP \<90 mm Hg and/or reduction of ≥5 mm Hg from baseline.
Time frame: Baseline to Week 24
Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg.
Percentage of subjects achieving target blood pressure Home BP SBP \<140 mm Hg.
Time frame: Baseline to Week 12
Percentage of subjects achieving target blood pressure Home BP DBP <90 mm Hg.
Percentage of subjects achieving target blood pressure Home BP SBP \<140 mm Hg.
Time frame: Baseline to Week 12
Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg and DBP <90 mm Hg.
Percentage of subjects achieving target blood pressure Home BP SBP \<140 mm Hg and DBP \<90 mm Hg.
Time frame: Baseline to Week 12
Percentage of subjects achieving target blood pressure Home BP DBP <80 mm Hg.
Percentage of subjects achieving target blood pressure Home BP DBP \<80 mm Hg.
Time frame: Baseline to Week 12
Percentage of subjects achieving target blood pressure Home BP SBP <130 mm Hg.
Percentage of subjects achieving target blood pressure Home BP SBP \<130 mm Hg.
Time frame: Baseline to Week 12
Percentage of subjects achieving target blood pressure Home BP SBP <130 mm Hg and DBP <80 mm Hg.
Percentage of subjects achieving target blood pressure Home BP SBP \<130 mm Hg and DBP \<80 mm Hg.
Time frame: Baseline to Week 12
Mean changes in weight
Mean changes in weight, expressed in Kilograms (Kg)
Time frame: Baseline to Week 12; Baseline to Week 24
Mean changes in BMI
Mean changes in Body Mass Index
Time frame: Baseline to Week 12; Baseline to Week 24
Mean changes in waist circumference
Mean changes in waist circumference, expressed in centimeters (cm).
Time frame: Baseline to Week 12; Baseline to Week 24
Mean change in points obtained by salt intake check sheet.
Mean change in points obtained by salt intake check sheet.
Time frame: Baseline to Week 12; Baseline to Week 24
Amicomed(R) app usage rate
Amicomed(R) app usage rate: Percentage of usage of Amicomed(R) app
Time frame: Baseline to Week 12; Baseline to Week 24
Amicomed(R) progress of app educational programs
Amicomed(R) progress of app educational programs
Time frame: Baseline to Week 12; Baseline to Week 24
Rate of home BP measurements
Weekly Rate of home BP measurements
Time frame: Baseline to Week 12; Baseline to Week 24
Malfunctions of the investigational medical device
Frequency of reported malfunctions of the investigational medical device
Time frame: Baseline to Week 12; Baseline to Week 24
Percentage of subjects on medication for Hypertension
Percentage of subjects on medication for Hypertension
Time frame: Baseline to Week 12; Baseline to Week 24