Pilot Study Based on Technology Solutions for Hypertension Care

NCT05818800 | Completed

• 1 other identifier: 09E801
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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)

Conditions

Hypertension; Blood Pressure

Keywords

Digital Technology; hypertension; blood pressure

Outcome Measures

Primary Outcomes (1)

• Changes in blood pressure

  The changes in systolic and diastolic blood pressure

  2 and 6 months

Secondary Outcomes (1)

• The user satisfaction measured with VAS

  2 and 6 months

Other Outcomes (1)

• Quality of life measured with EQ-5D

  2 and 6 months

Study Arms (3)

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.

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.

Device: digital solution

control

OTHER

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

Other: Standard Care

Interventions

digital solution DEVICE

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

Solution 1 - HSmartBPM (developed by a supplier consortium led by GNOMON); Solution 2 - HyperHealth (developed by a supplier consortium led by TECH4CARE)

Standard Care OTHER

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

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, 20149, Italy

Location

MeSH Terms

Conditions

Hypertension

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gianfranco Parati, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 19, 2023
• Study Start: December 17, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

IT (1)