Oral Anticoagulation and Self-management

NCT ID: NCT01878539

Last Updated: 2013-06-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Health Center training

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.

Group Type: EXPERIMENTAL

coagulometer

Intervention Type: DEVICE

training programme

Intervention Type: BEHAVIORAL

Interventions

coagulometer

Intervention Type: DEVICE

training programme

Intervention Type: BEHAVIORAL

Other Intervention Names

how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose; patient training programme involving the provision of information and practical training concerning their condition and its treatment

Eligibility Criteria

Inclusion Criteria

• Anticuagulated
• Living in the study area

Exclusion Criteria

• Older than 16 years old
• More than one year cuagulated

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Osakidetza

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Tamayo Aguirre

Family Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eduardo Tamayo, Doctor

Role: PRINCIPAL_INVESTIGATOR

Osakidetza

Locations

Osakidetza

Donostia / San Sebastian, Gipuzkoa, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Eduardo Tamayo, Doctor

Role: CONTACT

EDUARDO.TAMAYOAGUIRRE@osakidetza.net

0034-609180235

Facility Contacts

Eduardo Tamayo, Doctor

Role: primary

EDUARDO.TAMAYOAGUIRRE@osakidetza.net

0034-609180235

References

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.

Reference Type: DERIVED

PMID: 27624485 (View on PubMed)

Tamayo 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.

Reference Type: DERIVED

PMID: 23968316 (View on PubMed)

Other Identifiers

ISCIII-11/02285

Identifier Type: -

Identifier Source: org_study_id