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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03753568
• Other study ID #: 002
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: March 2019
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant Drugs
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• Electronic medicine reminder system
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.

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the medication	PDC - proportion of days covered	8 months
Secondary	Variation of daily pill taking times	The mean difference from the mean pill taking time	8 months