About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
adherence support system based on a vocal assistant
Other interventionParticipants 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 receive verbal advice from the physician about the need to follow the treatment recommendations and simple indications on possible solutions to maintain adherence, as by the usual practice of the Centre.
Treatment groups
Trial outcomes
Primary outcomes
Adherence (plasma essay - 3m)
Percentage of adherent patients based on plasma essay at follow-up visit
Secondary outcomes
adherence (pill count - 3m)
percentage of adherent patients based on pill count adherence (AdhVA) at follow-up visit
adherence (voice assistant - 3m)
percentage of adherent patients based on voice assistant adherence (AdhVA) at follow-up visit
adherence (questionnaire - 3m)
percentage of adherent patients based on MARS-5I (Medication Adherence Report Scale-5 Italian version) at follow-up visit
Adherence (plasma essay - 5m)
percentage of adherent patients based on plasma essay at final visit
Sponsors and contacts
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Istituto Auxologico Italiano
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborator
Politecnico di Milano
Collaborator