Pilot Study Based on Technology Solutions for Hypertension Care

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

digital solution

Standard Care

About this trial

This is an interventional other trial for Hypertension focused on measuring Digital Technology, hypertension, blood pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

Istituto Auxologico Italiano IRCCSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Solution 1 - HSmartBPM (developed by a supplier consortium led by GNOMON)

Solution 2 - HyperHealth (developed by a supplier consortium led by TECH4CARE)

control

Arm Description

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.

the control group where they will be followed according to standard care

Outcomes

Primary Outcome Measures

Changes in blood pressure

The changes in systolic and diastolic blood pressure

Secondary Outcome Measures

The user satisfaction measured with VAS

0-100 points VAS where 0 means not satisfied and 100 fully satisfied

Full Information

NCT ID

NCT05818800

First Posted

March 20, 2023

Last Updated

September 27, 2023

Sponsor

Istituto Auxologico Italiano

1. Study Identification

Unique Protocol Identification Number

NCT05818800

Brief Title

Pilot Study Based on Technology Solutions for Hypertension Care

Official Title

Pilot Study of Information and Communication Technology Solutions for Hypertension Care

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 17, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief 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. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Blood Pressure

Keywords

Digital Technology, hypertension, blood pressure

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Solution 1 - HSmartBPM (developed by a supplier consortium led by GNOMON)

Arm Type

Other

Arm Description

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.

Arm Title

Solution 2 - HyperHealth (developed by a supplier consortium led by TECH4CARE)

Arm Type

Other

Arm Description

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.

Arm Title

control

Arm Type

Other

Arm Description

the control group where they will be followed according to standard care

Intervention Type

Device

Intervention Name(s)

digital solution

Intervention Description

randomised controlled trial where patients with hypertension will be randomised either to one of the two digital solutions

Intervention Type

Other

Intervention Name(s)

Standard Care

Intervention Description

randomised controlled trial where patients with hypertension will be randomised r to standard care

Primary Outcome Measure Information:

Title

Changes in blood pressure

Description

The changes in systolic and diastolic blood pressure

Time Frame

2 and 6 months

Secondary Outcome Measure Information:

Title

The user satisfaction measured with VAS

Description

0-100 points VAS where 0 means not satisfied and 100 fully satisfied

Time Frame

2 and 6 months

Other Pre-specified Outcome Measures:

Title

Quality of life measured with EQ-5D

Description

EQ-5D is a standardised measure of health-related quality of life

Time Frame

2 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gianfranco Parati, MD

Phone

+39 02 61911

Ext

2903

Email

gianfranco.parati@unimib.it

First Name & Middle Initial & Last Name or Official Title & Degree

Martino Pengo, MD

Phone

+39 02 61911

Ext

2374

Email

m.pengo@auxologico.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gianfranco Parati, MD

Organizational Affiliation

Istituto Auxologico Italiano

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istituto Auxologico Italiano IRCCS

City

Milan

ZIP/Postal Code

20149

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

martino pengo, MD

Phone

0039 02619112374

Email

m.pengo@auxologico.it

Hypertension, Blood Pressure

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial