search
Back to results

Oral Anticoagulation and Self-management

Primary Purpose

Atrial Fibrillation, Embolism

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
coagulometer
training programme
Sponsored by
Osakidetza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Anticuagulated
  • Living in the study area

Exclusion Criteria:

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

Sites / Locations

  • OsakidetzaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health Center training

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 7, 2013
Last Updated
June 14, 2013
Sponsor
Osakidetza
Collaborators
Instituto de Salud Carlos III
search

1. Study Identification

Unique Protocol Identification Number
NCT01878539
Brief Title
Oral Anticoagulation and Self-management
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osakidetza
Collaborators
Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Embolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
333 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health Center training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
coagulometer
Other Intervention Name(s)
how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose
Intervention Type
Behavioral
Intervention Name(s)
training programme
Other Intervention Name(s)
patient training programme involving the provision of information and practical training concerning their condition and its treatment
Primary Outcome Measure Information:
Title
Control of INR (International Normalized Ratio)
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anticuagulated Living in the study area Exclusion Criteria: Older than 16 years old More than one year cuagulated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Tamayo, Doctor
Phone
0034-609180235
Email
EDUARDO.TAMAYOAGUIRRE@osakidetza.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Tamayo, Doctor
Organizational Affiliation
Osakidetza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osakidetza
City
Donostia-San Sebastian
State/Province
Gipuzkoa
ZIP/Postal Code
20003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Tamayo, Doctor
Phone
0034-609180235
Email
EDUARDO.TAMAYOAGUIRRE@osakidetza.net
First Name & Middle Initial & Last Name & Degree
Eduardo Tamayo, Doctor

12. IPD Sharing Statement

Citations:
PubMed Identifier
27624485
Citation
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.
Results Reference
derived
PubMed Identifier
23968316
Citation
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.
Results Reference
derived

Learn more about this trial

Oral Anticoagulation and Self-management

We'll reach out to this number within 24 hrs