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

Istituto Auxologico Italiano

Status: Not yet enrolling

Conditions: Hypertension; Digital Health; Treatment Adherence and Compliance

Treatments: Other: adherence support system based on a vocal assistant

Study type: Interventional

Funder types: Other

Identifiers

NCT06229171

09M201

Details and patient eligibility

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.

Enrollment: 206 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

usual practice

No Intervention group

vocal assistant

Experimental group

Treatment:

Other: adherence support system based on a vocal assistant