Oral Anticoagulation and Self-management
1 other identifier
interventional
333
1 country
1
Brief 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 factors associated with the success and failure of the program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 17, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 17, 2013
June 1, 2013
1 year
June 7, 2013
June 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 months
Study Arms (1)
Health Center training
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- Anticuagulated
- Living in the study area
You may not qualify if:
- Older than 16 years old
- More than one year cuagulated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Osakidetzalead
- Instituto de Salud Carlos IIIcollaborator
Study Sites (1)
Osakidetza
Donostia / San Sebastian, Gipuzkoa, 20003, Spain
Related Publications (2)
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.
PMID: 27624485DERIVEDTamayo 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.
PMID: 23968316DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo Tamayo, Doctor
Osakidetza
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Family Doctor
Study Record Dates
First Submitted
June 7, 2013
First Posted
June 17, 2013
Study Start
June 1, 2012
Primary Completion
June 1, 2013
Study Completion
December 1, 2014
Last Updated
June 17, 2013
Record last verified: 2013-06