InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: adherence support system based on a vocal assistant.
- Кому может быть актуально
- Состояния в реестре: Hypertension, Treatment Adherence and Compliance, Digital Health. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Вмешательства
- Другое 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 rec
Первичные конечные точки
- Adherence (plasma essay - 3m) [Срок оценки: after 3 months of randomized intervention]
Вторичные конечные точки (9)
- adherence (pill count - 3m) [Срок оценки: after 3 months of randomized intervention]
- adherence (voice assistant - 3m) [Срок оценки: after 3 months of randomized intervention]
- adherence (questionnaire - 3m) [Срок оценки: after 3 months of randomized intervention]
- Adherence (plasma essay - 5m) [Срок оценки: after 5 months]
- adherence (pill count - 5m) [Срок оценки: after 5 months]
- adherence (voice assistant - 5m) [Срок оценки: after 5 months]
- adherence (questionnaire - 5m) [Срок оценки: after 5 months]
- 24h Systolic Blood Pressure (3m) [Срок оценки: after 3 months of randomized intervention]
- 24h Systolic Blood Pressure (5m) [Срок оценки: after 5 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Италия · 1 центр
- San Luca Hospital, Istituto Auxologico Italiano IRCCS — Milan
Идентификаторы
NCT: NCT06229171 · 09M201