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临床试验/NCT06229171
NCT06229171招募中不适用

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

Istituto Auxologico Italiano2 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
206
试验地点
2
主要终点
Adherence (plasma essay - 3m)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Adherence (plasma essay - 3m)

时间窗: after 3 months of randomized intervention

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

次要结局

  • adherence (questionnaire - 3m)(after 3 months of randomized intervention)
  • adherence (questionnaire - 5m)(after 5 months)
  • 24h Systolic Blood Pressure (3m)(after 3 months of randomized intervention)
  • adherence (voice assistant - 3m)(after 3 months of randomized intervention)
  • Adherence (plasma essay - 5m)(after 5 months)
  • adherence (pill count - 5m)(after 5 months)
  • adherence (pill count - 3m)(after 3 months of randomized intervention)
  • adherence (voice assistant - 5m)(after 5 months)
  • 24h Systolic Blood Pressure (5m)(after 5 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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