Back to resultsEffect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
Primary Purpose
Anticoagulant Drugs, Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Electronic medicine reminder system
Sponsored by
About this trial
This is an interventional treatment trial for Anticoagulant Drugs focused on measuring medicine reminder, diabetes mellitus, type 2, direct oral anticoagulants
Eligibility 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
Sites / Locations
- Helsinki University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
The participants use either direct oral anticoagulants or oral diabetic medication.
Outcomes
Primary Outcome Measures
Adherence to the medication
PDC - proportion of days covered
Secondary Outcome Measures
Variation of daily pill taking times
The mean difference from the mean pill taking time
Full Information
NCT ID
NCT03753568
First Posted
November 21, 2018
Last Updated
March 21, 2019
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03753568
Brief Title
Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
Official Title
Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anticoagulant Drugs, Diabetes Mellitus, Type 2
Keywords
medicine reminder, diabetes mellitus, type 2, direct oral anticoagulants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects are monitored first before the intervention and then during the intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
The participants use either direct oral anticoagulants or oral diabetic medication.
Intervention Type
Device
Intervention Name(s)
Electronic medicine reminder system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to the medication
Description
PDC - proportion of days covered
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Variation of daily pill taking times
Description
The mean difference from the mean pill taking time
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leo Niskanen, M.D. Ph.D
Phone
+358500675727
Email
leo.niskanen@fimnet.fi
First Name & Middle Initial & Last Name & Degree
Janne Sahlman, M.D. Ph.D
Phone
+358405586611
Email
janne.m.sahlman@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
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