HypertensionNCT05818800
Pilot Study Based on Technology Solutions for Hypertension Care
A study testing digital solution in people with Hypertension and Blood Pressure, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Blood Pressure
- What is being tested?
- digital solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 17 Dec 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with essential hypertension (>140/90 mmHg or normal BP with antihypertensive treatment)
- Basic ICT knowledge and ability to access the internet at home and on mobile devices
- aged 18+
- ability to provide written informed consent, giving informed consent.
- written informed consent
Who cannot join
- inability to consent
- chronic renal replacement therapy (haemodialysis, peritoneal dialysis or transplantation) or if, at baseline, there is a history of active malignancy within the last five years
- pregnancy
- illiterate
- younger than 18 years
- being a prisoner
Show all 16Show fewer
- being institutionalized
- the patient is mentally or psychiatrically ill
- the patient has barriers to understand the implications of participation to the study
- the patient is critically ill or dying
- the patient is extremely poor
- the patient has a learning disability
- the patient is sedated or unconscious
- the patient is a refugee with no permanent permission to stay
- the patient does not have a good command of the language
- the patient has problems in cognitive, juridical, and deferential dimensions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Information and Communication Technology Solutions for Hypertension Care
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:
Read more
- are these digital solutions feasible and well accepted by patients?
- can these solutions, compared to standard care, allow a better hypertension control in patients with high blood pressure?
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)
Read the detailed description
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:
- Solution 1 - HSmartBPM (developed by a supplier consortium led by GNOMON)
- Solution 2 - HyperHealth (developed by a supplier consortium led by TECH4CARE)
- Conditions
- Hypertension, Blood Pressure
- Being tested
- digital solution, Standard Care
- Keywords
- Digital Technology, hypertension, blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital solutionDevice
randomised controlled trial where patients with hypertension will be randomised either to one of the two digital solutions
Standard CareOther
randomised controlled trial where patients with hypertension will be randomised r to standard care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: digital solution |
| 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. Receives: Device: digital solution |
| control | Other | the control group where they will be followed according to standard care Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood pressure
The changes in systolic and diastolic blood pressure
Measured: 2 and 6 months
Secondary outcomes (1)
The user satisfaction measured with VAS
0-100 points VAS where 0 means not satisfied and 100 fully satisfied
Measured: 2 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start17 Dec 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianfranco Parati, MD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818800
- Sponsor's protocol ID
- 09E801
- Status last verified
- Feb 2024
- First submitted
- 20 Mar 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Information and Communication Technology Solutions for Hypertension Care
- ClinicalTrials.gov ID
- NCT05818800
- Acronym / sponsor ID
- 09E801
- Conditions
- Hypertension, Blood Pressure
- Keywords
- Digital Technology, hypertension, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 17 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- are these digital solutions feasible and well accepted by patients?
- can these solutions, compared to standard care, allow a better hypertension control in patients with high blood pressure?
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)
Detailed description
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:
- Solution 1 - HSmartBPM (developed by a supplier consortium led by GNOMON)
- Solution 2 - HyperHealth (developed by a supplier consortium led by TECH4CARE)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Solution 1 - HSmartBPM (developed by a supplier consortium led by GNOMON) | Other | Device: digital solutionSolutions 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 | Device: digital solutionSolutions 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 | Other: Standard Carethe control group where they will be followed according to standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with essential hypertension (>140/90 mmHg or normal BP with antihypertensive treatment)
- Basic ICT knowledge and ability to access the internet at home and on mobile devices
- aged 18+
- ability to provide written informed consent, giving informed consent.
- written informed consent
Key exclusion criteria (16 listed)
- inability to consent
- chronic renal replacement therapy (haemodialysis, peritoneal dialysis or transplantation) or if, at baseline, there is a history of active malignancy within the last five years
- pregnancy
- illiterate
- younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital solutionrandomised controlled trial where patients with hypertension will be randomised either to one of the two digital solutions | Device | Solution 1 - HSmartBPM (developed by a supplier consortium led by GNOMON), Solution 2 - HyperHealth (developed by a supplier consortium led by TECH4CARE) |
| Standard Carerandomised controlled trial where patients with hypertension will be randomised r to standard care | Other | control |
Primary outcome
Changes in blood pressure
Time frame: 2 and 6 months
The changes in systolic and diastolic blood pressure
1 secondary outcome
The user satisfaction measured with VAS
Time frame: 2 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianfranco Parati, MD principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital solution in people with Hypertension and Blood Pressure, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood pressure (time frame: 2 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.