RecruitingNot ApplicableNCT06229171

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

Sponsor

Istituto Auxologico Italiano

Enrollment

206 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Hypertension Digital Health Treatment Adherence and Compliance

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and testing a digital health tool — using a voice assistant device — to help patients with high blood pressure take their blood pressure medications more consistently. The goal is to improve medication adherence and cardiovascular health. **You may be eligible if...** - You are an adult (over 18) with a history of essential high blood pressure - You are taking at least one blood pressure medication included in the study's monitoring list - You have a wireless internet connection at home - You are in stable health **You may NOT be eligible if...** - You are not comfortable using technology or voice assistants - You have dementia or significant psychiatric disorders - You have conditions that significantly affect your ability to speak (deafness, major speech disorders, or poor knowledge of Italian) - You are pregnant or breastfeeding - You have an active cancer (except a minor skin cancer) - You have had an upper limb amputation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERadherence 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.