Clinical trial NCT06229171: InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention
Official title: InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Treatment Adherence and Compliance
Digital Health
Keywords: Personalized Medicine
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: Istituti Clinici Scientifici Maugeri SpA
name: Politecnico di Milano
First posted: 2024-01-29
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence (plasma essay - 3m)
timeFrame: after 3 months of randomized intervention
Secondary outcomes:
measure: adherence (pill count - 3m)
timeFrame: after 3 months of randomized intervention
measure: adherence (voice assistant - 3m)
timeFrame: after 3 months of randomized intervention
measure: adherence (questionnaire - 3m)
timeFrame: after 3 months of randomized intervention
measure: Adherence (plasma essay - 5m)
timeFrame: after 5 months
measure: adherence (pill count - 5m)
timeFrame: after 5 months
measure: adherence (voice assistant - 5m)
timeFrame: after 5 months
measure: adherence (questionnaire - 5m)
timeFrame: after 5 months
measure: 24h Systolic Blood Pressure (3m)
timeFrame: after 3 months of randomized intervention
measure: 24h Systolic Blood Pressure (5m)
timeFrame: after 5 months
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Auxologico Italiano
name: Grzegorz Bilo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: