InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: adherence support system based on a vocal assistant.
- Who it may be relevant to
- Registry conditions: Hypertension, Treatment Adherence and Compliance, Digital Health. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 rec
Primary outcome measures
- Adherence (plasma essay - 3m) [Time frame: after 3 months of randomized intervention]
Secondary outcome measures (9)
- adherence (pill count - 3m) [Time frame: after 3 months of randomized intervention]
- adherence (voice assistant - 3m) [Time frame: after 3 months of randomized intervention]
- adherence (questionnaire - 3m) [Time frame: after 3 months of randomized intervention]
- Adherence (plasma essay - 5m) [Time frame: after 5 months]
- adherence (pill count - 5m) [Time frame: after 5 months]
- adherence (voice assistant - 5m) [Time frame: after 5 months]
- adherence (questionnaire - 5m) [Time frame: after 5 months]
- 24h Systolic Blood Pressure (3m) [Time frame: after 3 months of randomized intervention]
- 24h Systolic Blood Pressure (5m) [Time frame: after 5 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 1 center
- San Luca Hospital, Istituto Auxologico Italiano IRCCS — Milan
Identifiers
NCT: NCT06229171 · 09M201