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

March 21, 2019 updated by: Janne Sahlman, Helsinki University Central Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
The participants use either direct oral anticoagulants or oral diabetic medication.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2019

Primary Completion (Anticipated)

July 30, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

November 22, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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