Self-management of Anticoagulation Treatment

Study Overview
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Brief Summary
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The aim of the study was to compare self-management of anticoagulant treatment with conventional anticoagulant treatment in Norway.

Detailed Description
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Patients (n=132) on anticoagulant treatment with warfarin participated in a 21 weeks training program where they learned how to analyse International Normalised Ratio (INR) using the point-of-care instrument CoaguChek®XS and dose warfarin. The patients had to display their skills through a test before considered self-managing. They continued to measure INR weekly for two years. All INR values during the training program and self-control period were collected. In addition, the patients were told to notify if they had any complications during this period. INR values and complications two years before enrolment was collected from INR cards and/or their general practioner. The participant filled in a quality of life-questioner at enrolment and after two years of self-management.

Official Title
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Comparison Between Conventional Anticoagulation Treatment and Self-management of Anticoagulation Treatment

Conditions
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Atrial Fibrillation, Venous Thromboembolism, Artificial Heart Valve

Intervention / Treatment
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* Other: Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: On life-long oral anticoagulation therapy Judged to be qualified for patient self-management anticoagulation treatment by their GP Motivated to follow the training program Exclusion Criteria: Drug abuse Liver disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional treatment<br>Conventional anticoagulation treatment Before enrolment | |
| Experimental: Self-management<br>Trained to monitor INR and dose warfarin | Other: Training<br>* Patients were trained to measure INR and dose warfarin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Time in therapeutic range (TTR) | Change in TTR from conventional treatment to self-management | From two years before enrolment until two years of self management | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of complications | Compare number of complications during conventional treatment and during self-management | From two years before enrolment until two years of self management | 
| Quality of life (QoL) |  | Baseline before training and after two years with self-management | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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warfarin, self-management, Conventional management, Training, TTR, Complications, Quality of life