Oral Anticoagulation and Self-management

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01878539
• Other study ID #: ISCIII-11/02285
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2013
• Last updated: June 14, 2013
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: June 2013
• Source: Osakidetza
• Contact: Eduardo Tamayo, Doctor
• Phone: 0034-609180235
• Email: EDUARDO.TAMAYOAGUIRRE[@]osakidetza.net
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical 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 factors associated with the success and failure of the program.

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism

Intervention

Device:
• coagulometer

Behavioral:
• training programme

Locations

Country	Name	City	State
Spain	Osakidetza	Donostia-San Sebastian	Gipuzkoa

Sponsors (2)

Lead Sponsor	Collaborator
Osakidetza	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

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