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

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ClinicalTrials.gov Identifier: NCT03753568
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Janne Sahlman, 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.

Condition or disease Intervention/treatment Phase
Anticoagulant Drugs Diabetes Mellitus, Type 2 Device: Electronic medicine reminder system Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects are monitored first before the intervention and then during the intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Study group
The participants use either direct oral anticoagulants or oral diabetic medication.
Device: Electronic medicine reminder system
The smart phone application reminds the participants to take their medicine if they are about to take their daily dosage.




Primary Outcome Measures :
  1. Adherence to the medication [ Time Frame: 8 months ]
    PDC - proportion of days covered


Secondary Outcome Measures :
  1. Variation of daily pill taking times [ Time Frame: 8 months ]
    The mean difference from the mean pill taking time



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753568


Locations
Finland
Helsinki University Hospital Recruiting
Helsinki, Finland, 00029
Contact: Leo Niskanen, M.D. Ph.D    +358500675727    leo.niskanen@fimnet.fi   
Contact: Janne Sahlman, M.D. Ph.D    +358405586611    janne.m.sahlman@gmail.com   
Sponsors and Collaborators
Helsinki University Central Hospital

Responsible Party: Janne Sahlman, Chief medical officer, Popit Ltd, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03753568     History of Changes
Other Study ID Numbers: 002
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janne Sahlman, Helsinki University Central Hospital:
medicine reminder
diabetes mellitus, type 2
direct oral anticoagulants

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anticoagulants