Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-02 @ 7:34 AM
Study NCT ID:
NCT03753568
Status:
UNKNOWN
Last Update Posted:
2019-03-25
First Post:
2018-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
Sponsor:
Helsinki University Central Hospital
Organization:
Study Overview
Official Title:
Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: