Clinical trial NCT05818800: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Blood Pressure
Keywords: Digital Technology
hypertension
blood pressure
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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)

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

Primary outcomes:
measure: Changes in blood pressure
timeFrame: 2 and 6 months
Secondary outcomes:
measure: The user satisfaction measured with VAS
timeFrame: 2 and 6 months
Other outcomes:
measure: Quality of life measured with EQ-5D
timeFrame: 2 and 6 months
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
Study officials:
affiliation: Istituto Auxologico Italiano
name: Gianfranco Parati, MD
role: PRINCIPAL_INVESTIGATOR
References: