Long-term Oral Anticoagulant TherapyNCT02371772
Self-management of Anticoagulation Treatment
A study testing Training in people with Long-term Oral Anticoagulant Therapy, run by Una Ørvim Sølvik.
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
- Long-term Oral Anticoagulant Therapy
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Sep 2009
- 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
- Live in Bergen municipality
- 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=23) on anticoagulant treatment with warfarin participated in a 27 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 28 weeks. 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. Ten INR values and complications 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 28 weeks of self-management.
- Conditions
- Long-term Oral Anticoagulant Therapy
- Being tested
- Training
- Keywords
- Warfarin, Self Care, Conventional care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Patients were trained to monitor INR and dose warfarin
| Study group | Role | What they receive |
|---|---|---|
| Self-management anticoagulation treatment | Other | Trained to monitor INR and dose warfarin Receives: Other: Training |
| Conventional anticoagulation treatment | No intervention | Before enrolment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time in therapeutic range (TTR)
Measured: From 39 weeks before enrolment until 28 weeks of self management
Secondary outcomes (1)
Change in number of complications
Measured: From 39 weeks before enrolment until 28 weeks of self management
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startAug 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term Oral Anticoagulant TherapyStudies 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
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Una Ørvim Sølvik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Una Ørvim Sølvik, University of Bergen
- Investigators
- Una Ø Sølvik, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371772
- Sponsor's protocol ID
- UBergen
- Status last verified
- Feb 2015
- First submitted
- 11 Feb 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. 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
- NCT02371772
- Acronym / sponsor ID
- UBergen
- Conditions
- Long-term Oral Anticoagulant Therapy
- Keywords
- Warfarin, Self Care, Conventional care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Una Ørvim SølvikUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Feb 2015 (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=23) on anticoagulant treatment with warfarin participated in a 27 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 28 weeks. 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. Ten INR values and complications 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 28 weeks of self-management.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-management anticoagulation treatment | Other | Other: TrainingTrained to monitor INR and dose warfarin |
| Conventional anticoagulation treatment | No intervention | –Before enrolment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- on life-long oral anticoagulation therapy
- Live in Bergen municipality
- 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 monitor INR and dose warfarin | Other | Self-management anticoagulation treatment |
Primary outcome
Change in Time in therapeutic range (TTR)
Time frame: From 39 weeks before enrolment until 28 weeks of self management
1 secondary outcome
Change in number of complications
Time frame: From 39 weeks before enrolment until 28 weeks of 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 26 Feb 2015.
Related trials for Long-term Oral Anticoagulant Therapy
RecruitingObservational study
The Association Between Non-vitamin K Antagonist Oral Anticoagulant Therapy and Acute Stroke Severity and Post Stroke Short-term and Long-term Outcomes.
Therapeutic Drug Monitoring
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 Long-term Oral Anticoagulant Therapy, run by Una Ørvim Sølvik.
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 4 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 26 Feb 2015. 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 39 weeks before enrolment until 28 weeks 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 26 Feb 2015.