Atrial FibrillationNCT01878539
Oral Anticoagulation and Self-management
A study testing coagulometer and training programme in people with Atrial Fibrillation and Embolism, run by Osakidetza at 1 site in Spain.
Trial summary
An intervention program targeting patients and caregivers based on education about their condition and training in the use of portable coagulomenter to self monitor and training on the treatment adjustment to self manage, can be effective to enable patients in OACs to self manage as well as to identify determinant… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Atrial Fibrillation, Embolism
- What is being tested?
- coagulometer and training programme
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to Dec 2014
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Anticuagulated
- Living in the study area
Who cannot join
- Older than 16 years old
- More than one year cuagulated
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Osakidetza
Donostia / San Sebastian, Gipuzkoa, 20003
Eduardo Tamayo, Doctor, 0034-609180235, EDUARDO.TAMAYOAGUIRRE@osakidetza.net
Eduardo Tamayo, Doctor
About this study
Official title: Oral Anticoagulation and Self-management: Analysis of the Factors That Determine the Feasibility of Using Self-testing and Self-management in Primary Care
An intervention program targeting patients and caregivers based on education about their condition and training in the use of portable coagulomenter to self monitor and training on the treatment adjustment to self manage, can be effective to enable patients in OACs to self manage as well as to identify determinant factors associated with the success and failure of the program.
Read the detailed description
BACKGROUND: The skills of patients on oral anticoagulants are critical for achieving good outcomes with this treatment. Self-management, or the capacity of patients to control their INR (International Normalized Ratio)level and adjust their treatment, is an effective strategy of treatment. Capacity of patients to self manage is determined by a range of factors. The identification of these factors would improve the design of self management programmes and in turn increase the number of patients able to self-manage. The objective of our study is to identify those factors that determine the ability of patients on oral anticoagulant therapy to achieve self-management of their treatment.
METHOD: This will be a three year quasi- experimental prospective study with a control group. 333 patients on anticoagulant therapy from five health centres of the Basque Health Service are to be followed up for a period of six months each after the intervention, to assess their ability to self-test and self-manage. The intervention will consist of a patient training programme involving the provision of information and practical training concerning their condition and its treatment, as well as how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose.
DISCUSSION: Training programmes for self-management are effective in terms of enabling patients to acquire the necessary skills, though the level of success seems to depend on various patient-related factors. Given the proven benefits of self-management, it would be useful to properly characterise these factors and use this information to successfully increase the percentage of patients on on oral anticoagulants able to self-manage their own treatment.
- Conditions
- Atrial Fibrillation, Embolism
- Being tested
- coagulometer, training programme
- Medical subject headings
- Atrial Fibrillation, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coagulometerDevice
Also called how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose
training programmeBehavioural
Also called patient training programme involving the provision of information and practical training concerning their condition and its treatment
| Study group | Role | What they receive |
|---|---|---|
| Health Center training | Experimental | The intervention will consist of a patient training programme involving the provision of information and practical training concerning their condition and its treatment, as well as how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose. Receives: Device: coagulometer; Behavioral: training programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of INR (International Normalized Ratio)
So the primary objectives of this study are to assess the ability of patients/caregivers to test INR (International Normalized Ratio) levels with a portable coagulometer and capillary whole blood from a finger prick and the impact of a range of factors on the ability of patients on OACs to self-monitor and self-manage their treatment.
If the INR is within the personal range above 80% it will consider a good control
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osakidetza
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Eduardo Tamayo Aguirre, Osakidetza
- Investigators
- Eduardo Tamayo, Doctor, Principal investigator, Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878539
- Sponsor's protocol ID
- ISCIII-11/02285
- Status last verified
- Jun 2013
- First submitted
- 7 Jun 2013
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tamayo Aguirre E, Galo-Anza A, Dorronsoro-Barandiaran O, Del Burgo EU, Ostiza Irigoyen A, Garcia-Carro A, Lopez-Fernandez I, Colera N, Saez-Garbayo P, Tamayo-Uria I. Oral anticoagulation with vitamin K inhibitors and determinants of successful self-management in primary care. BMC Cardiovasc Disord. 2016 Sep 13;16(1):180. doi: 10.1186/s12872-016-0326-z.
PubMed 27624485Tamayo Aguirre E, Vergara-Mitxeltorena I, Uranga Saez Del Burgo E, Ostiza-Irigoyen A, Garcia-Carro A, Lopez-Fernandez I, Galo-Anza A. Oral anticoagulation and self-management: analysis of the factors that determine the feasibility of using self-testing and self-management in primary care. BMC Cardiovasc Disord. 2013 Aug 22;13:59. doi: 10.1186/1471-2261-13-59.
PubMed 23968316
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Anticoagulation and Self-management: Analysis of the Factors That Determine the Feasibility of Using Self-testing and Self-management in Primary Care
- ClinicalTrials.gov ID
- NCT01878539
- Acronym / sponsor ID
- ISCIII-11/02285
- Conditions
- Atrial Fibrillation, Embolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 333 participants (estimated)
- Lead sponsor
- OsakidetzaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 17 Jun 2013 (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.
An intervention program targeting patients and caregivers based on education about their condition and training in the use of portable coagulomenter to self monitor and training on the treatment adjustment to self manage, can be effective to enable patients in OACs to self manage as well as to identify determinant factors associated with the success and failure of the program.
Detailed description
BACKGROUND: The skills of patients on oral anticoagulants are critical for achieving good outcomes with this treatment. Self-management, or the capacity of patients to control their INR (International Normalized Ratio)level and adjust their treatment, is an effective strategy of treatment. Capacity of patients to self manage is determined by a range of factors. The identification of these factors would improve the design of self management programmes and in turn increase the number of patients able to self-manage. The objective of our study is to identify those factors that determine the ability of patients on oral anticoagulant therapy to achieve self-management of their treatment.
METHOD: This will be a three year quasi- experimental prospective study with a control group. 333 patients on anticoagulant therapy from five health centres of the Basque Health Service are to be followed up for a period of six months each after the intervention, to assess their ability to self-test and self-manage. The intervention will consist of a patient training programme involving the provision of information and practical training concerning their condition and its treatment, as well as how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose.
DISCUSSION: Training programmes for self-management are effective in terms of enabling patients to acquire the necessary skills, though the level of success seems to depend on various patient-related factors. Given the proven benefits of self-management, it would be useful to properly characterise these factors and use this information to successfully increase the percentage of patients on on oral anticoagulants able to self-manage their own treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Center training | Experimental | Device: coagulometer, Behavioral: training programmeThe intervention will consist of a patient training programme involving the provision of information and practical training concerning their condition and its treatment, as well as how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Anticuagulated
- Living in the study area
Key exclusion criteria (2 listed)
- Older than 16 years old
- More than one year cuagulated
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 |
|---|---|---|
| coagulometerAlso: how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose | Device | Health Center training |
| training programmeAlso: patient training programme involving the provision of information and practical training concerning their condition and its treatment | Behavioural | Health Center training |
Primary outcome
Control of INR (International Normalized Ratio)
Time frame: 6 months
So the primary objectives of this study are to assess the ability of patients/caregivers to test INR (International Normalized Ratio) levels with a portable coagulometer and capillary whole blood from a finger prick and the impact of a range of factors on the ability of patients on OACs to self-monitor and self-manage their treatment. If the INR is within the personal range above 80% it will consider a good control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
- Derived from this study: PubMed 27624485Tamayo Aguirre E, Galo-Anza A, Dorronsoro-Barandiaran O, Del Burgo EU, Ostiza Irigoyen A, Garcia-Carro A, Lopez-Fernandez I, Colera N, Saez-Garbayo P, Tamayo-Uria I. Oral anticoagulation with vitamin K inhibitors and determinants of successful self-management in primary care. BMC Cardiovasc Disord. 2016 Sep 13;16(1):180. doi: 10.1186/s12872-016-0326-z.
- Derived from this study: PubMed 23968316Tamayo Aguirre E, Vergara-Mitxeltorena I, Uranga Saez Del Burgo E, Ostiza-Irigoyen A, Garcia-Carro A, Lopez-Fernandez I, Galo-Anza A. Oral anticoagulation and self-management: analysis of the factors that determine the feasibility of using self-testing and self-management in primary care. BMC Cardiovasc Disord. 2013 Aug 22;13:59. doi: 10.1186/1471-2261-13-59.
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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.
Eduardo Tamayo, Doctor principal investigator
Osakidetza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coagulometer and training programme in people with Atrial Fibrillation and Embolism, run by Osakidetza at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 17 Jun 2013. 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 Spain. 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?
Contact Eduardo Tamayo, Doctor (0034-609180235, EDUARDO.TAMAYOAGUIRRE@osakidetza.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of INR (International Normalized Ratio) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01878539, which also lists 2 linked publications.
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 17 Jun 2013.