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NCT05818800Completed

Pilot Study Based on Technology Solutions for Hypertension Care

Pilot Study of Information and Communication Technology Solutions for Hypertension Care

Source: ClinicalTrials.gov · Last updated 29 Feb 2024

Brief summary (registry, in English)

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)

Status (registry)
Completed
Study type
Interventional
Enrollment
65 (actual)
First submitted
20 Mar 2023
Start date
17 Dec 2022
Primary completion date
31 Dec 2023
Lead sponsor
Istituto Auxologico Italiano
NCT number
NCT05818800

What you commit to

  • Study type: Interventional
  • Participants enrolled: 65
  • From 17 Dec 2022 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Age

  • younger than 18 years

Other

  • inability to consent
  • pregnancy
  • illiterate
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Istituto Auxologico Italiano IRCCS
Coordinator of this site? Confirm its status
MilanItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.