Pilot Study Based on Technology Solutions for Hypertension Care

Hypertension Clinical Trial

Official title:

Pilot Study of Information and Communication Technology Solutions for Hypertension Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05818800
• Other study ID #: 09E801
• Status: Completed
• Phase: N/A
• Start date: December 17, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

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

Other:
• Standard Care
randomised controlled trial where patients with hypertension will be randomised r to standard care

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCCS	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life measured with EQ-5D	EQ-5D is a standardised measure of health-related quality of life	2 and 6 months
Primary	Changes in blood pressure	The changes in systolic and diastolic blood pressure	2 and 6 months
Secondary	The user satisfaction measured with VAS	0-100 points VAS where 0 means not satisfied and 100 fully satisfied	2 and 6 months