Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06229171

InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention

Led by Istituto Auxologico Italiano · Updated on 2025-08-21

206

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

I

Istituto Auxologico Italiano

Lead Sponsor

I

Istituti Clinici Scientifici Maugeri SpA

Collaborating Sponsor

AI-Summary

What this Trial Is About

Inadequate medication adherence (MA) in chronic conditions, including cardiovascular prevention, represents an important risk factor. The use of new IT technologies in this setting is supposed to be useful to improve patients' adherence, but currently available solutions have significant limitations, including lack of personalization and reliance on expensive ad hoc systems. This interdisciplinary project aims to verify the hypothesis that in patients on chronic antihypertensive treatment MA can be improved through the implementation of a novel digital health solution for MA monitoring and support, based on inexpensive and user-friendly, commercially available technology (voice assistant), connected with web interface for the physician. The intervention will be personalized based on the creation of Personas, intended as multidisciplinary-based representations of different user types. This approach will be tested in a randomized clinical trial.

CONDITIONS

Official Title

InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (>18 years old) patients
  • History of essential hypertension
  • Treatment with at least one antihypertensive drug with available plasma assay
  • Wireless internet connection available at patient's home
  • Stable clinical conditions
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Insufficient technological literacy to manage vocal assistant
  • Dementia or significant psychiatric disorders
  • Conditions limiting vocal communication (deafness, significant speech disorders, poor knowledge of Italian)
  • Pregnancy or breastfeeding
  • Active cancer (except basal cell skin carcinoma)
  • Upper limb amputation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

San Luca Hospital, Istituto Auxologico Italiano IRCCS

Milan, Italy, 20149

Actively Recruiting

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Research Team

G

Grzegorz Bilo, MD, PhD

CONTACT

L

Lucia Zanotti, Bsc, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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