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The goal of this clinical trial is to understand whether the adoption of digital solutions by healthcare professionals and patients improves the management of patients with high blood pressure.
The main questions it aims to answer are:
Participants randomised to one of the two intervention arms will be asked to adopt the digital solutions that include a smartphone app and 2 devices for blood pressure and body weight measurement that will be connected to the app.
Researchers will compare patients randomised in the two intervention groups with patients randomised to standard care (control group)
The study falls within the scope of the HSMonitor project, a pre-commercial tender for the development of telematics solutions aimed at optimising patient health status and disease management. Specifically, the aim of this study is to test whether the adoption of HSMonitor solutions by healthcare professionals and patients improves the management of patients with high blood pressure.
This will be a randomised controlled trial where patients with hypertension will be randomised either to one of the two digital solutions or to standard care.
The present pilot study is planned to be carried out within the framework of the EU project HSMonitor - Pre-commercial Procurement of innovative ICT-enabled monitoring to improve health status and optimize hypertension care (Grant Agreement Nr. 856698).
The two solutions are referred to as:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solution 1 - HSmartBPM (developed by a supplier consortium led by GNOMON) | Other | Solutions consist of devices (e.g., blood pressure monitors, body composition scales) working together in an ecosystem enabled by a user-facing service and associated interfaces. Users are invited to a dedicated training session at the pilot site to officially become enrolled and begin using the solution for an extended period of time. During that time, users are instructed to use the solutions based on recommendations by their treating physicians (e.g., regular measurement of blood pressure using the solution, or scheduling of regular visits via the solution interface). Questionnaires are administered via the solution's interface at the beginning and end of the trial duration. At the end of the trial, the user is asked to return the devices to the pilot site. |
|
| Solution 2 - HyperHealth (developed by a supplier consortium led by TECH4CARE) | Other | Solutions consist of devices (e.g., blood pressure monitors, body composition scales) working together in an ecosystem enabled by a user-facing service and associated interfaces. Users are invited to a dedicated training session at the pilot site to officially become enrolled and begin using the solution for an extended period of time. During that time, users are instructed to use the solutions based on recommendations by their treating physicians (e.g., regular measurement of blood pressure using the solution, or scheduling of regular visits via the solution interface). Questionnaires are administered via the solution's interface at the beginning and end of the trial duration. At the end of the trial, the user is asked to return the devices to the pilot site. |
|
| control | Other | the control group where they will be followed according to standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| digital solution | Device | randomised controlled trial where patients with hypertension will be randomised either to one of the two digital solutions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood pressure | The changes in systolic and diastolic blood pressure | 2 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The user satisfaction measured with VAS | 0-100 points VAS where 0 means not satisfied and 100 fully satisfied | 2 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life measured with EQ-5D | EQ-5D is a standardised measure of health-related quality of life | 2 and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianfranco Parati, MD | Istituto Auxologico Italiano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Auxologico Italiano IRCCS | Milan | 20149 | Italy |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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This will be a randomised controlled trial where patients with hypertension will be randomised either to one of the two digital solutions or to standard care.
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| Standard Care | Other | randomised controlled trial where patients with hypertension will be randomised r to standard care |
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