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

Not Applicable

• Conditions: Anticoagulant Drugs; Diabetes Mellitus, Type 2
• Interventions: Device: Electronic medicine reminder system

• Registration Number: NCT03753568
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-22
• Study First Posted: 2018-11-27
• Status Verified: 2019-03
• Study Start: 2019-03-20
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25
• Primary Completion: 2019-07-30
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Electronic medicine reminder system	The participants use either direct oral anticoagulants or oral diabetic medication.

Primary Outcome Measures

Name	Time	Method
Adherence to the medication	8 months	PDC - proportion of days covered

Secondary Outcome Measures

Name	Time	Method
Variation of daily pill taking times	8 months	The mean difference from the mean pill taking time

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland