Recruiting

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

ClinicalTrials.gov IDNCT06229171

PhaseNA

Enrollment206

SponsorIstituto Auxologico Italiano

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Hypertension, Treatment Adherence and Compliance, Digital Health

About this study

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.

Interventions

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.

Primary outcomes

Adherence (plasma essay - 3m) (after 3 months of randomized intervention)

Eligibility information

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 locations

San Luca Hospital, Istituto Auxologico Italiano IRCCS, Milan, 20149 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.