Anticoagulant DrugsNCT03753568
Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
A study testing Electronic medicine reminder system in people with Anticoagulant Drugs and Diabetes Mellitus, Type 2, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anticoagulant Drugs, Diabetes Mellitus, Type 2
- What is being tested?
- Electronic medicine reminder system
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 20 Mar 2019to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- use of direct oral anticoagulants or oral diabetic drugs
- age of 18 or more
- subjects have been using a smart phone
Who cannot join
- patients who don't use their medication without help
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, 00029
Leo Niskanen, M.D. Ph.D, +358500675727, leo.niskanen@fimnet.fi
Janne Sahlman, M.D. Ph.D, +358405586611, janne.m.sahlman@gmail.com
About this study
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.
Read the 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.
- Conditions
- Anticoagulant Drugs, Diabetes Mellitus, Type 2
- Being tested
- Electronic medicine reminder system
- Keywords
- medicine reminder, diabetes mellitus, type 2, direct oral anticoagulants
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic medicine reminder systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The participants use either direct oral anticoagulants or oral diabetic medication. Receives: Device: Electronic medicine reminder system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the medication
PDC - proportion of days covered
Measured: 8 months
Secondary outcomes (1)
Variation of daily pill taking times
The mean difference from the mean pill taking time
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start20 Mar 2019
- Primary completion30 Jul 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulant DrugsStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects are monitored first before the intervention and then during the intervention.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janne Sahlman, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753568
- Sponsor's protocol ID
- 002
- Status last verified
- Mar 2019
- First submitted
- 21 Nov 2018
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence
- ClinicalTrials.gov ID
- NCT03753568
- Acronym / sponsor ID
- 002
- Conditions
- Anticoagulant Drugs, Diabetes Mellitus, Type 2
- Keywords
- medicine reminder, diabetes mellitus, type 2, direct oral anticoagulants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects are monitored first before the intervention and then during the intervention.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Electronic medicine reminder systemThe participants use either direct oral anticoagulants or oral diabetic medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- use of direct oral anticoagulants or oral diabetic drugs
- age of 18 or more
- subjects have been using a smart phone
Key exclusion criteria (1 listed)
- patients who don't use their medication without help
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic medicine reminder systemElectronic 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. | Device | Study group |
Primary outcome
Adherence to the medication
Time frame: 8 months
PDC - proportion of days covered
1 secondary outcome
Variation of daily pill taking times
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic medicine reminder system in people with Anticoagulant Drugs and Diabetes Mellitus, Type 2, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the medication (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.