Atrial Fibrillation Clinical Trial
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.
Status | Recruiting |
Enrollment | 333 |
Est. completion date | December 2014 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Anticuagulated - Living in the study area Exclusion Criteria: - Older than 16 years old - More than one year cuagulated |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | Osakidetza | Donostia-San Sebastian | Gipuzkoa |
Lead Sponsor | Collaborator |
---|---|
Osakidetza | Instituto de Salud Carlos III |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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