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Completed

NCT Number: NCT05818800

Pilot Study Based on 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:

* 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)

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Key information

Conditions

Hypertension Blood Pressure Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Auxologico Italiano IRCCS

Milan, 20149, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

digital solution

Device

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

Standard care

Other

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

Primary outcomes

  1. Changes in blood pressure

    Time frame: 2 and 6 months

    The changes in systolic and diastolic blood pressure

Secondary outcomes

  1. The user satisfaction measured with VAS

    Time frame: 2 and 6 months

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

Other outcomes

  1. Quality of life measured with EQ-5D

    Time frame: 2 and 6 months

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

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

Pilot Study of Information and Communication Technology Solutions for Hypertension Care

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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