Essential Hypertension, Primary Hypertension
Conditions
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.
Interventions
DEVICEAmicomed®
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.
DEVICEDigital Placebo
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.
OTHERUsual Care
Usual Care (UC): Subjects assigned to control group will receive care as usual care, including self-monitoring indications.
Sponsors
Newel Health SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 <140 mm Hg. | Baseline to Week 12 | Percentage of subjects achieving target blood pressure Home BP SBP \<140 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. |
| 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 DBP <80 mm Hg. | 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 SBP <130 mm Hg. | Baseline to Week 12 | Percentage of subjects achieving target blood pressure Home BP SBP \<130 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 |
| Mean changes in waist circumference | Baseline to Week 12; Baseline to Week 24 | Mean changes in waist circumference, expressed in centimeters (cm). |
| 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. |
| 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 |
| Amicomed(R) progress of app educational programs | Baseline to Week 12; Baseline to Week 24 | Amicomed(R) progress of app educational programs |
| Rate of home BP measurements | Baseline to Week 12; Baseline to Week 24 | Weekly Rate of home BP measurements |
| 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 on medication for Hypertension | Baseline to Week 12; Baseline to Week 24 | Percentage of subjects on medication for Hypertension |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Any adverse events including device-related adverse events. | Baseline to Week 12; Baseline to Week 24 | Any adverse events including device-related adverse events. |
Contacts
Primary ContactGiovanni Gentile, MSc
Outcome results
None listed