Oral Anticoagulation and Self-management

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.

Study Overview

• Status: Unknown
• Conditions: Embolism; Atrial Fibrillation
• Intervention / Treatment: Device: coagulometer; Behavioral: training programme

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 Type: Interventional
• Enrollment (Anticipated): 333
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eduardo Tamayo, Doctor; Phone Number: 0034-609180235; Email: EDUARDO.TAMAYOAGUIRRE@osakidetza.net

Study Locations

• Spain
  • Gipuzkoa
    • Donostia-San Sebastian, Gipuzkoa, Spain, 20003
      • Recruiting
      • Osakidetza
      • Contact: Eduardo Tamayo, Doctor; Phone Number: 0034-609180235; Email: EDUARDO.TAMAYOAGUIRRE@osakidetza.net
      • Principal Investigator: Eduardo Tamayo, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Anticuagulated
• Living in the study area

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: coagulometer; Other Names: how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose; Behavioral: training programme; Other Names: patient training programme involving the provision of information and practical training concerning their condition and its treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Osakidetza
• Collaborators: Instituto de Salud Carlos III
• Investigators: Principal Investigator: Eduardo Tamayo, Doctor, Osakidetza

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: June 7, 2013
• First Submitted That Met QC Criteria: June 14, 2013
• First Posted (Estimate): June 17, 2013

Study Record Updates

• Last Update Posted (Estimate): June 17, 2013
• Last Update Submitted That Met QC Criteria: June 14, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Embolism; Atrial Fibrillation; Anticoagulants
• Other Study ID Numbers: ISCIII-11/02285

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No