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临床试验/NCT03753568
NCT03753568Unknown不适用

Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence

Helsinki University Central Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Adherence to the medication

研究概览

简要总结

In this study, the effect of an electronic device attached to a push through pill package and a smart phone application on chronic disease medication adherence is studied.

详细描述

In this study study two different groups of medicine users are recruited. Both groups have 50 patients each. In the first study the participants are using oral medication for diabetes and in the second study the participants use new direct oral anticoagulants.

Participants use medicine reminder system consisting of an electronic device and an smart phone application. In the beginning of the study the reminder system is collecting data on how the patients are taking their medication for the first two months. Smart phone application is not providing any reminders and participants can't access the app to see the details.

After two months the application will be unlocked so that it starts reminding the users to take their medication at the right time. in this phase the patients can view their medication data from the application. The reminder phase of the study lasts for two months. After these two plus two months, the results are analyzed and published.

The study continues after these four months for the next four months and after that, the long term results are analyzed.'

The primary outcome is the possible change in the adherence between control and active period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • use of direct oral anticoagulants or oral diabetic drugs
  • age of 18 or more
  • subjects have been using a smart phone

排除标准

  • patients who don't use their medication without help

研究组 & 干预措施

Study group

Experimental

The participants use either direct oral anticoagulants or oral diabetic medication.

干预措施: Electronic medicine reminder system (Device)

结局指标

主要结局

Adherence to the medication

时间窗: 8 months

PDC - proportion of days covered

次要结局

  • Variation of daily pill taking times(8 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Janne Sahlman

Chief medical officer, Popit Ltd

Helsinki University Central Hospital

研究点 (2)

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