InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention
- Conditions
- HypertensionDigital HealthTreatment Adherence and Compliance
- Interventions
- Other: adherence support system based on a vocal assistant
- Registration Number
- NCT06229171
- Lead Sponsor
- Istituto Auxologico Italiano
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 206
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vocal assistant adherence support system based on a vocal assistant -
- Primary Outcome Measures
Name Time Method Adherence (plasma essay - 3m) after 3 months of randomized intervention Percentage of adherent patients based on plasma essay at follow-up visit
- Secondary Outcome Measures
Name Time Method adherence (questionnaire - 3m) after 3 months of randomized intervention percentage of adherent patients based on MARS-5I (Medication Adherence Report Scale-5 Italian version) at follow-up visit
adherence (questionnaire - 5m) after 5 months percentage of adherent patients based on MARS-5I at final visit
24h Systolic Blood Pressure (3m) after 3 months of randomized intervention 24-hour systolic blood pressure (ABPM) at follow-up visit
adherence (voice assistant - 3m) after 3 months of randomized intervention percentage of adherent patients based on voice assistant adherence (AdhVA) at follow-up visit
Adherence (plasma essay - 5m) after 5 months percentage of adherent patients based on plasma essay at final visit
adherence (pill count - 5m) after 5 months percentage of adherent patients based on pill count adherence (AdhVA) at final visit
adherence (pill count - 3m) after 3 months of randomized intervention percentage of adherent patients based on pill count adherence (AdhVA) at follow-up visit
adherence (voice assistant - 5m) after 5 months percentage of adherent patients based on voice assistant adherence (AdhVA) at final visit
24h Systolic Blood Pressure (5m) after 5 months 24-hour systolic blood pressure (ABPM) at final visit