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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
206
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 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.
San Luca Hospital, Istituto Auxologico Italiano IRCCS
Milan, Italy
RECRUITINGAdherence (plasma essay - 3m)
Percentage of adherent patients based on plasma essay at follow-up visit
Time frame: after 3 months of randomized intervention
adherence (pill count - 3m)
percentage of adherent patients based on pill count adherence (AdhVA) at follow-up visit
Time frame: after 3 months of randomized intervention
adherence (voice assistant - 3m)
percentage of adherent patients based on voice assistant adherence (AdhVA) at follow-up visit
Time frame: after 3 months of randomized intervention
adherence (questionnaire - 3m)
percentage of adherent patients based on MARS-5I (Medication Adherence Report Scale-5 Italian version) at follow-up visit
Time frame: after 3 months of randomized intervention
Adherence (plasma essay - 5m)
percentage of adherent patients based on plasma essay at final visit
Time frame: after 5 months
adherence (pill count - 5m)
percentage of adherent patients based on pill count adherence (AdhVA) at final visit
Time frame: after 5 months
adherence (voice assistant - 5m)
percentage of adherent patients based on voice assistant adherence (AdhVA) at final visit
Time frame: after 5 months
adherence (questionnaire - 5m)
percentage of adherent patients based on MARS-5I at final visit
Time frame: after 5 months
24h Systolic Blood Pressure (3m)
24-hour systolic blood pressure (ABPM) at follow-up visit
Time frame: after 3 months of randomized intervention
24h Systolic Blood Pressure (5m)
24-hour systolic blood pressure (ABPM) at final visit
Time frame: after 5 months
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