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| Name | Class |
|---|---|
| Istituti Clinici Scientifici Maugeri SpA | OTHER |
| Politecnico di Milano | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual practice | No Intervention | ||
| vocal assistant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adherence support system based on a vocal assistant | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence (plasma essay - 3m) | Percentage of adherent patients based on plasma essay at follow-up visit | after 3 months of randomized intervention |
| Measure | Description | Time Frame |
|---|---|---|
| adherence (pill count - 3m) | percentage of adherent patients based on pill count adherence (AdhVA) at follow-up visit | after 3 months of randomized intervention |
| adherence (voice assistant - 3m) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grzegorz Bilo, MD, PhD | Contact | +390261911 | 2903 | g.bilo@auxologico.it |
| Lucia Zanotti, Bsc, PhD | Contact | +390261911 | 2714 | l.zanotti@auxologico.it |
| Name | Affiliation | Role |
|---|---|---|
| Grzegorz Bilo, MD, PhD | Istituto Auxologico Italiano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Luca Hospital, Istituto Auxologico Italiano IRCCS | Recruiting | Milan | 20149 | Italy |
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|
percentage of adherent patients based on voice assistant adherence (AdhVA) at follow-up visit
| 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 | after 3 months of randomized intervention |
| Adherence (plasma essay - 5m) | percentage of adherent patients based on plasma essay at final visit | after 5 months |
| adherence (pill count - 5m) | percentage of adherent patients based on pill count adherence (AdhVA) at final visit | after 5 months |
| adherence (voice assistant - 5m) | percentage of adherent patients based on voice assistant adherence (AdhVA) at final visit | after 5 months |
| adherence (questionnaire - 5m) | percentage of adherent patients based on MARS-5I at final visit | after 5 months |
| 24h Systolic Blood Pressure (3m) | 24-hour systolic blood pressure (ABPM) at follow-up visit | after 3 months of randomized intervention |
| 24h Systolic Blood Pressure (5m) | 24-hour systolic blood pressure (ABPM) at final visit | after 5 months |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
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