Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Adherence to the medication
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Study group
The participants use either direct oral anticoagulants or oral diabetic medication.
Intervention: Electronic medicine reminder system (Device)
Outcomes
Primary Outcomes
Adherence to the medication
Time Frame: 8 months
PDC - proportion of days covered
Secondary Outcomes
- Variation of daily pill taking times(8 months)
Investigators
Janne Sahlman
Chief medical officer, Popit Ltd
Helsinki University Central Hospital