Actively Recruiting
InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention
Led by Istituto Auxologico Italiano · Updated on 2025-08-21
206
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Istituto Auxologico Italiano
Lead Sponsor
I
Istituti Clinici Scientifici Maugeri SpA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a new digital health solution using a voice assistant can help improve medication adherence in adults with essential hypertension who are on chronic antihypertensive treatment. The study aims to address the challenges of current adherence tools by offering a personalized, user-friendly, and cost-effective system that connects patients and physicians through voice reminders and a web interface. This interdisciplinary randomized clinical trial is sponsored by Istituto Auxologico Italiano. Participants will be randomly assigned to one of two groups: the intervention group will receive a vocal assistant device for home use that reminds them when to take their medication and allows them to confirm adherence vocally within 30 minutes. The control group will receive standard verbal advice from their physician about following treatment recommendations. The intervention will be tailored using Personas, which are multidisciplinary representations of different user types, to personalize support. Throughout the study, participants will be monitored for medication adherence using several methods including plasma assays, pill counts, voice assistant records, and questionnaires at 3 and 5 months after starting the intervention. Blood pressure will also be measured at these time points. The research team will assess adherence and blood pressure changes to determine the impact of the vocal assistant system. The total participation duration covers at least 5 months of follow-up after randomization.
CONDITIONS
Brief Title
InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (over 18 years old) patients
- History of essential hypertension
- Treatment with at least one antihypertensive drug for which a dedicated plasma assay is available
- Wireless internet connection available at patient's home
- Stable clinical conditions
- Written informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 months
Participants receive either a vocal assistant device to support medication adherence at home or verbal advice about treatment adherence following usual practice.
Visits as needed for device setup and adherence monitoring
Trial Site Locations
Total: 1 location
1
San Luca Hospital, Istituto Auxologico Italiano IRCCS
Milan, Italy, 20149
Actively Recruiting
Research Team
G
Grzegorz Bilo, MD, PhD
L
Lucia Zanotti, Bsc, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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