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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Auxologico Italiano

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • adherence support system based on a vocal assistant

    Other intervention

    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.

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: usual practiceNo intervention 0 interventions
Group B: vocal assistantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adherence (plasma essay - 3m)

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

Time frame
after 3 months of randomized intervention

Secondary outcomes

1

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
2

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
3

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
4

Adherence (plasma essay - 5m)

percentage of adherent patients based on plasma essay at final visit

Time frame
after 5 months

Other outcomes

Sponsors and contacts

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Istituto Auxologico Italiano

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborator

Politecnico di Milano

Collaborator