Assessment of Efficacy and Safety of Amicomed®, for the Management of Essential Hypertension
- Conditions
- Essential HypertensionPrimary Hypertension
- Interventions
- Device: Amicomed®Device: Digital PlaceboOther: Usual Care
- Registration Number
- NCT06091176
- Lead Sponsor
- Newel Health SRL
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 316
- 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 1.
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Amicomed® Subjects assigned to ID1 treatment arm will receive Amicomed® for 90 days, together with Usual Care (UC) procedures. Arm 2 Usual Care Subjects assigned to ID2 treatment arm, will receive a digital Placebo, together with UC for 90 days. Arm 1 Usual Care Subjects assigned to ID1 treatment arm will receive Amicomed® for 90 days, together with Usual Care (UC) procedures. Arm 2 Digital Placebo Subjects assigned to ID2 treatment arm, will receive a digital Placebo, together with UC for 90 days.
- Primary Outcome Measures
Name Time Method Change in Home Blood Pressure Monitoring - Systolic Blood Pressure 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 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 Outcome Measures
Name Time Method 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 responders who show at Week 12 Home BP SBP \<140 mm Hg and/or a reduction of ≥5 mm Hg from baseline.
Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg. Baseline to Week 12 Percentage of subjects achieving target blood pressure Home BP SBP \<140 mm Hg.
The change from baseline to Week 24 in trough Home BP Systolic Blood Pressure Baseline to Week 24 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.The change from baseline to Week 24 in trough Home BP Diastolic Blood Pressure Baseline to Week 24 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.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 responders who show at Week 24 Home BP SBP \<140 mm Hg and/or a reduction of ≥5 mm Hg from baseline.
Percentage of subjects achieving target blood pressure Home BP DBP <80 mm Hg. Baseline to Week 12 Percentage of subjects achieving target blood pressure Home BP DBP \<80 mm Hg.
Mean changes in weight Baseline to Week 12; Baseline to Week 24 Mean changes in weight, expressed in Kilograms (Kg)
Mean changes in BMI Baseline to Week 12; Baseline to Week 24 Mean changes in Body Mass Index
Amicomed(R) progress of app educational programs Baseline to Week 12; Baseline to Week 24 Amicomed(R) progress of app educational programs
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 who show at Week 12 Home BP DBP \<90 mm Hg and/or a reduction of ≥5 mm Hg from baseline.
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 responders who show at Week 24 Home BP DBP \<90 mm Hg and/or reduction of ≥5 mm Hg from baseline.
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 SBP \<130 mm Hg.
Percentage of subjects achieving target blood pressure Home BP DBP <90 mm Hg. Baseline to Week 12 Percentage of subjects achieving target blood pressure Home BP SBP \<140 mm Hg.
Mean change in points obtained by salt intake check sheet. Baseline to Week 12; Baseline to Week 24 Mean change in points obtained by salt intake check sheet.
Malfunctions of the investigational medical device Baseline to Week 12; Baseline to Week 24 Frequency of reported malfunctions of the investigational medical device
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 \<140 mm Hg and DBP \<90 mm Hg.
Percentage of subjects achieving target blood pressure Home BP SBP <130 mm Hg and DBP <80 mm Hg. Baseline to Week 12 Percentage of subjects achieving target blood pressure Home BP SBP \<130 mm Hg and DBP \<80 mm Hg.
Mean changes in waist circumference Baseline to Week 12; Baseline to Week 24 Mean changes in waist circumference, expressed in centimeters (cm).
Rate of home BP measurements Baseline to Week 12; Baseline to Week 24 Weekly Rate of home BP measurements
Percentage of subjects on medication for Hypertension Baseline to Week 12; Baseline to Week 24 Percentage of subjects on medication for Hypertension
Amicomed(R) app usage rate Baseline to Week 12; Baseline to Week 24 Amicomed(R) app usage rate: Percentage of usage of Amicomed(R) app