InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention

Hypertension Clinical Trial

— InTakeCare  

Official title:

InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06229171
• Other study ID #: 09M201
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Digital Health
• Hypertension
• Treatment Adherence and Compliance

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