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

August 19, 2025 updated by: Istituto Auxologico Italiano

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milano, Italy, 20149
        • Recruiting
        • San Luca Hospital, Istituto Auxologico Italiano IRCCS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult (>18 years old) patients
  • History of essential hypertension
  • Treatment with at least one antihypertensive drug for which dedicated plasma essay is available
  • wireless internet connection available at patients' home
  • stable clinical conditions
  • written informed consent

Exclusion Criteria:

  • insufficient technological literacy to manage vocal assistant
  • dementia or significant psychiatric disorders
  • conditions significantly limiting vocal communication (deafness, significant speech disorders, poor knowledge of Italian language)
  • pregnancy or breastfeeding
  • active cancer (except basal cell skin carcinoma)
  • upper limb amputation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: usual practice
Experimental: vocal assistant
Other: adherence support system based on a vocal assistant

Participants in the intervention group will receive a vocal assistant device and the instructions/support for the activation of the system at their homes. The device will remind the participant, at the times defined during set-up, which therapy should be taken and with what dosage. The participant will have 30 minutes from the first reminder to confirm vocally that the therapy has been taken, which will otherwise be considered as not having been taken.

Participants in the control group will receive verbal advice from the physician about the need to follow the treatment recommendations and simple indications on possible solutions to maintain adherence, as by the usual practice of the Centre.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence (plasma essay - 3m)
Time Frame: after 3 months of randomized intervention
Percentage of adherent patients based on plasma essay at follow-up visit
after 3 months of randomized intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adherence (pill count - 3m)
Time Frame: after 3 months of randomized intervention
percentage of adherent patients based on pill count adherence (AdhVA) at follow-up visit
after 3 months of randomized intervention
adherence (voice assistant - 3m)
Time Frame: after 3 months of randomized intervention
percentage of adherent patients based on voice assistant adherence (AdhVA) at follow-up visit
after 3 months of randomized intervention
adherence (questionnaire - 3m)
Time Frame: after 3 months of randomized intervention
percentage of adherent patients based on MARS-5I (Medication Adherence Report Scale-5 Italian version) at follow-up visit
after 3 months of randomized intervention
Adherence (plasma essay - 5m)
Time Frame: after 5 months
percentage of adherent patients based on plasma essay at final visit
after 5 months
adherence (pill count - 5m)
Time Frame: after 5 months
percentage of adherent patients based on pill count adherence (AdhVA) at final visit
after 5 months
adherence (voice assistant - 5m)
Time Frame: after 5 months
percentage of adherent patients based on voice assistant adherence (AdhVA) at final visit
after 5 months
adherence (questionnaire - 5m)
Time Frame: after 5 months
percentage of adherent patients based on MARS-5I at final visit
after 5 months
24h Systolic Blood Pressure (3m)
Time Frame: after 3 months of randomized intervention
24-hour systolic blood pressure (ABPM) at follow-up visit
after 3 months of randomized intervention
24h Systolic Blood Pressure (5m)
Time Frame: after 5 months
24-hour systolic blood pressure (ABPM) at final visit
after 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Collaborators

Istituti Clinici Scientifici Maugeri SpA
Politecnico di Milano

Investigators

  • Principal Investigator: Grzegorz Bilo, MD, PhD, Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09M201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on adherence support system based on a vocal assistant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe