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

NCT06229171 | Recruiting

• 1 other identifier: 09M201
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hypertension; Treatment Adherence and Compliance; Digital Health

Keywords

Personalized Medicine

Outcome Measures

Primary Outcomes (1)

• Adherence (plasma essay - 3m)

  Percentage of adherent patients based on plasma essay at follow-up visit

  after 3 months of randomized intervention

Secondary Outcomes (9)

• adherence (pill count - 3m)

  after 3 months of randomized intervention

• adherence (voice assistant - 3m)

  after 3 months of randomized intervention

• adherence (questionnaire - 3m)

  after 3 months of randomized intervention

• Adherence (plasma essay - 5m)

  after 5 months

• adherence (pill count - 5m)

  after 5 months

Study Arms (2)

usual practice

NO INTERVENTION

vocal assistant

EXPERIMENTAL

Other: adherence support system based on a vocal assistant

Interventions

adherence support system based on a vocal assistant OTHER

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.

vocal assistant

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator
• Politecnico di Milano: collaborator

Study Sites (1)

San Luca Hospital, Istituto Auxologico Italiano IRCCS

Milan, 20149, Italy

RECRUITING

MeSH Terms

Conditions

Hypertension; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Health Behavior; Behavior

Study Officials

• Grzegorz Bilo, MD, PhD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grzegorz Bilo, MD, PhD

CONTACT

+390261911; g.bilo@auxologico.it

Lucia Zanotti, Bsc, PhD

CONTACT

+390261911; l.zanotti@auxologico.it

Study Design

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

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

IT (1)