A Multicenter, Randomized, Parallel-Group, Single-Blind Study to Compare the Efficacy and Safety of Amicomed®, for the Management of Essential Hypertension
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Essential Hypertension
- Sponsor
- Newel Health SRL
- Enrollment
- 316
- Primary Endpoint
- Change in Home Blood Pressure Monitoring - Systolic Blood Pressure
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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 and/or 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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female with age ≥ 18 years
- •Diagnosed with essential hypertension and exhibiting a mean home-based SBP ≥ 140 and/or DBP \> 90mm Hg, i.e., Grade I Hypertension .
- •Disease duration: 12 (+/-) 3 months
- •Unmedicated, or currently treated by a stable regimen for hypertension with sub-optimal response to usual care treatments (Delta SBP \< 5 mm Hg; and/or Delta DBP \< 5 mm Hg)
- •Not participating in physical exercise or dietary programs during the last 12 months from Visit
- •Willing and able to return for all clinic visits and to complete all study-required procedures
- •Able to use the app, \[self-report compliance over 80%\]. Compliance is defined as the capacity to provide at least 6 BP measurements per week during the beginning, middle and end week of the 24 weeks program.
Exclusion Criteria
- •Pregnancy or planning to become pregnant during the study period
- •Use of medications that may interfere with the study intervention
- •Severe kidney or liver disease
- •Active cancer treatment
Outcomes
Primary Outcomes
Change in Home Blood Pressure Monitoring - Systolic Blood Pressure
Time Frame: Baseline to Week 12
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.
Change in Home Blood Pressure Monitoring - Dyastolic Blood Pressure
Time Frame: Baseline to Week 12
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.
Secondary Outcomes
- Percentage of responders at Week 12 Home BP SBP <140 mm Hg and/or reduction of ≥5 mm Hg from baseline.(Baseline to Week 12)
- Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg.(Baseline to Week 12)
- The change from baseline to Week 24 in trough Home BP Systolic Blood Pressure(Baseline to Week 24)
- The change from baseline to Week 24 in trough Home BP Diastolic Blood Pressure(Baseline to Week 24)
- Percentage of responders at Week 24 Home BP SBP <140 mm Hg and/or reduction of ≥5 mm Hg from baseline.(Baseline to Week 24)
- Percentage of subjects achieving target blood pressure Home BP DBP <80 mm Hg.(Baseline to Week 12)
- Mean changes in weight(Baseline to Week 12; Baseline to Week 24)
- Mean changes in BMI(Baseline to Week 12; Baseline to Week 24)
- Amicomed(R) progress of app educational programs(Baseline to Week 12; 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.(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.(Baseline to Week 24)
- Percentage of subjects achieving target blood pressure Home BP SBP <130 mm Hg.(Baseline to Week 12)
- Percentage of subjects achieving target blood pressure Home BP DBP <90 mm Hg.(Baseline to Week 12)
- Mean change in points obtained by salt intake check sheet.(Baseline to Week 12; Baseline to Week 24)
- Malfunctions of the investigational medical device(Baseline to Week 12; Baseline to Week 24)
- Percentage of subjects on medication for Hypertension(Baseline to Week 12; Baseline to Week 24)
- Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg and DBP <90 mm Hg.(Baseline to Week 12)
- Percentage of subjects achieving target blood pressure Home BP SBP <130 mm Hg and DBP <80 mm Hg.(Baseline to Week 12)
- Mean changes in waist circumference(Baseline to Week 12; Baseline to Week 24)
- Rate of home BP measurements(Baseline to Week 12; Baseline to Week 24)
- Amicomed(R) app usage rate(Baseline to Week 12; Baseline to Week 24)