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

NCT ID: NCT03753568

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2019-09-01

Brief Summary

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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

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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.

Conditions

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Anticoagulant Drugs Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Subjects are monitored first before the intervention and then during the intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

The participants use either direct oral anticoagulants or oral diabetic medication.

Group Type EXPERIMENTAL

Electronic medicine reminder system

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Janne Sahlman

Chief medical officer, Popit Ltd

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helsinki University Hospital

Helsinki, , Finland

Site Status RECRUITING

Countries

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Finland

Facility Contacts

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Leo Niskanen, M.D. Ph.D

Role: primary

+358500675727

Janne Sahlman, M.D. Ph.D

Role: backup

+358405586611

Other Identifiers

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002

Identifier Type: -

Identifier Source: org_study_id

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