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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06229171
Other study ID # 09M201
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2024
Est. completion date April 1, 2026

Study information

Verified date January 2024
Source Istituto Auxologico Italiano
Contact Grzegorz Bilo, MD, PhD
Phone +390261911
Email g.bilo@auxologico.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 206
Est. completion date April 1, 2026
Est. primary completion date April 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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 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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Istituto Auxologico Italiano Istituti Clinici Scientifici Maugeri SpA, Politecnico di Milano

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence (plasma essay - 3m) Percentage of adherent patients based on plasma essay at follow-up visit after 3 months of randomized intervention
Secondary adherence (pill count - 3m) percentage of adherent patients based on pill count adherence (AdhVA) at follow-up visit after 3 months of randomized intervention
Secondary adherence (voice assistant - 3m) percentage of adherent patients based on voice assistant adherence (AdhVA) at follow-up visit after 3 months of randomized intervention
Secondary 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
Secondary Adherence (plasma essay - 5m) percentage of adherent patients based on plasma essay at final visit after 5 months
Secondary adherence (pill count - 5m) percentage of adherent patients based on pill count adherence (AdhVA) at final visit after 5 months
Secondary adherence (voice assistant - 5m) percentage of adherent patients based on voice assistant adherence (AdhVA) at final visit after 5 months
Secondary adherence (questionnaire - 5m) percentage of adherent patients based on MARS-5I at final visit after 5 months
Secondary 24h Systolic Blood Pressure (3m) 24-hour systolic blood pressure (ABPM) at follow-up visit after 3 months of randomized intervention
Secondary 24h Systolic Blood Pressure (5m) 24-hour systolic blood pressure (ABPM) at final visit after 5 months
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