Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
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|ClinicalTrials.gov Identifier: NCT03753568|
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anticoagulant Drugs Diabetes Mellitus, Type 2||Device: Electronic medicine reminder system||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects are monitored first before the intervention and then during the intervention.|
|Masking:||None (Open Label)|
|Official Title:||Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence|
|Actual Study Start Date :||November 21, 2018|
|Estimated Primary Completion Date :||January 30, 2019|
|Estimated Study Completion Date :||September 1, 2019|
Experimental: Study group
The participants use either direct oral anticoagulants or oral diabetic medication.
Device: Electronic medicine reminder system
The smart phone application reminds the participants to take their medicine if they are about to take their daily dosage.
- Adherence to the medication [ Time Frame: 8 months ]PDC - proportion of days covered
- Variation of daily pill taking times [ Time Frame: 8 months ]The mean difference from the mean pill taking time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753568
|Helsinki University Hospital||Recruiting|
|Helsinki, Finland, 00029|
|Contact: Leo Niskanen, M.D. Ph.D +358500675727 email@example.com|
|Contact: Janne Sahlman, M.D. Ph.D +358405586611 firstname.lastname@example.org|