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NCT Number: NCT06229171

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

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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Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Digital Health Health Behavior Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Luca Hospital, Istituto Auxologico Italiano IRCCS

Milan, 20149, Italy

Location status: Recruiting

Location contact

Lucia Zanotti

CONTACT

[email protected]

+39 02 619112714

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Adherence (plasma essay - 3m)

    Time frame: after 3 months of randomized intervention

    Percentage of adherent patients based on plasma essay at follow-up visit

Secondary outcomes

  1. adherence (pill count - 3m)

    Time frame: after 3 months of randomized intervention

    percentage of adherent patients based on pill count adherence (AdhVA) at follow-up visit

  2. adherence (voice assistant - 3m)

    Time frame: after 3 months of randomized intervention

    percentage of adherent patients based on voice assistant adherence (AdhVA) at follow-up visit

  3. adherence (questionnaire - 3m)

    Time frame: after 3 months of randomized intervention

    percentage of adherent patients based on MARS-5I (Medication Adherence Report Scale-5 Italian version) at follow-up visit

  4. Adherence (plasma essay - 5m)

    Time frame: after 5 months

    percentage of adherent patients based on plasma essay at final visit

  5. adherence (pill count - 5m)

    Time frame: after 5 months

    percentage of adherent patients based on pill count adherence (AdhVA) at final visit

  6. adherence (voice assistant - 5m)

    Time frame: after 5 months

    percentage of adherent patients based on voice assistant adherence (AdhVA) at final visit

  7. adherence (questionnaire - 5m)

    Time frame: after 5 months

    percentage of adherent patients based on MARS-5I at final visit

  8. 24h Systolic Blood Pressure (3m)

    Time frame: after 3 months of randomized intervention

    24-hour systolic blood pressure (ABPM) at follow-up visit

  9. 24h Systolic Blood Pressure (5m)

    Time frame: after 5 months

    24-hour systolic blood pressure (ABPM) at final visit

Study contacts

Contact information is provided by the study sponsor or research team.

Grzegorz Bilo, MD, PhD

CONTACT

[email protected]

+390261911 ext. 2903

Lucia Zanotti, Bsc, PhD

CONTACT

[email protected]

+390261911 ext. 2714

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Collaborators

  • Istituti Clinici Scientifici Maugeri SpA
  • Politecnico di Milano

Registry information

Acronym: InTakeCare

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2024
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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