Atrial FibrillationNCT02864537
Self-management of Anticoagulation Treatment
A study testing Training in people with Atrial Fibrillation and Venous Thromboembolism, run by University of Bergen.
Trial summary
The aim of the study was to compare self-management of anticoagulant treatment with conventional anticoagulant treatment in Norway. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation, Venous Thromboembolism, Artificial Heart Valve
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Mar 2013
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On life-long oral anticoagulation therapy
- Judged to be qualified for patient self-management anticoagulation treatment by their GP
- Motivated to follow the training program
Who cannot join
- Drug abuse
- Liver disease
About this study
Official title: Comparison Between Conventional Anticoagulation Treatment and Self-management of Anticoagulation Treatment
The aim of the study was to compare self-management of anticoagulant treatment with conventional anticoagulant treatment in Norway.
Read the detailed description
Patients (n=132) on anticoagulant treatment with warfarin participated in a 21 weeks training program where they learned how to analyse International Normalised Ratio (INR) using the point-of-care instrument CoaguChek®XS and dose warfarin. The patients had to display their skills through a test before considered self-managing. They continued to measure INR weekly for two years. All INR values during the training program and self-control period were collected. In addition, the patients were told to notify if they had any complications during this period. INR values and complications two years before enrolment was collected from INR cards and/or their general practioner. The participant filled in a quality of life-questioner at enrolment and after two years of self-management.
- Being tested
- Training
- Keywords
- warfarin, self-management, Conventional management, Training, TTR, Complications, Quality of life
- Medical subject headings
- Atrial Fibrillation, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Patients were trained to measure INR and dose warfarin
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | No intervention | Conventional anticoagulation treatment Before enrolment |
| Self-management | Experimental | Trained to monitor INR and dose warfarin Receives: Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time in therapeutic range (TTR)
Change in TTR from conventional treatment to self-management
Measured: From two years before enrolment until two years of self management
Secondary outcomes (2)
Change in number of complications
Compare number of complications during conventional treatment and during self-management
Measured: From two years before enrolment until two years of self management
Quality of life (QoL)
Measured: Baseline before training and after two years with self-management
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startJan 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Una Ørvim Sølvik, University of Bergen
- Investigators
- Una Ø Sølvik, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864537
- Sponsor's protocol ID
- Lokkebo
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Conventional Anticoagulation Treatment and Self-management of Anticoagulation Treatment
- ClinicalTrials.gov ID
- NCT02864537
- Acronym / sponsor ID
- Lokkebo
- Keywords
- warfarin, self-management, Conventional management, Training, TTR, Complications, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Aug 2016 (estimated)
- 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.
The aim of the study was to compare self-management of anticoagulant treatment with conventional anticoagulant treatment in Norway.
Detailed description
Patients (n=132) on anticoagulant treatment with warfarin participated in a 21 weeks training program where they learned how to analyse International Normalised Ratio (INR) using the point-of-care instrument CoaguChek®XS and dose warfarin. The patients had to display their skills through a test before considered self-managing. They continued to measure INR weekly for two years. All INR values during the training program and self-control period were collected. In addition, the patients were told to notify if they had any complications during this period. INR values and complications two years before enrolment was collected from INR cards and/or their general practioner. The participant filled in a quality of life-questioner at enrolment and after two years of self-management.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | No intervention | –Conventional anticoagulation treatment Before enrolment |
| Self-management | Experimental | Other: TrainingTrained to monitor INR and dose warfarin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- On life-long oral anticoagulation therapy
- Judged to be qualified for patient self-management anticoagulation treatment by their GP
- Motivated to follow the training program
Key exclusion criteria (2 listed)
- Drug abuse
- Liver disease
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 |
|---|---|---|
| TrainingPatients were trained to measure INR and dose warfarin | Other | Self-management |
Primary outcome
Change in Time in therapeutic range (TTR)
Time frame: From two years before enrolment until two years of self management
Change in TTR from conventional treatment to self-management
2 secondary outcomes
Change in number of complications
Time frame: From two years before enrolment until two years of self management
Quality of life (QoL)
Time frame: Baseline before training and after two years with self-management
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- 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.
Una Ø Sølvik, PhD principal investigator
University of Bergen
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Atrial Fibrillation and Venous Thromboembolism, run by University of Bergen.
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 2 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: finished, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Time in therapeutic range (TTR) (time frame: From two years before enrolment until two years of self management). 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 12 Aug 2016.