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

Study Overview
=================
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.

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

Conditions
-----------------
Anticoagulant Drugs, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Device: Electronic medicine reminder system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: use of direct oral anticoagulants or oral diabetic drugs age of 18 or more subjects have been using a smart phone Exclusion Criteria: patients who don't use their medication without help

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects are monitored first before the intervention and then during the intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>The participants use either direct oral anticoagulants or oral diabetic medication. | Device: Electronic medicine reminder system<br>* Electronic surveillance device is attached to the participants push through pill sheet and the smart phone application reminds the participants to take their medicine if they are about to take their daily dosage.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the medication | PDC - proportion of days covered | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of daily pill taking times | The mean difference from the mean pill taking time | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medicine reminder, diabetes mellitus, type 2, direct oral anticoagulants