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OpenTrials
Completed

NCT Number: NCT02864537

Self-management of Anticoagulation Treatment

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Artificial Heart Valve Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training

Other

Patients were trained to measure INR and dose warfarin

Primary outcomes

  1. Change in Time in therapeutic range (TTR)

    Time frame: From two years before enrolment until two years of self management

    Change in TTR from conventional treatment to self-management

Secondary outcomes

  1. Change in number of complications

    Time frame: From two years before enrolment until two years of self management

    Compare number of complications during conventional treatment and during self-management

  2. Quality of life (QoL)

    Time frame: Baseline before training and after two years with self-management

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 12, 2016
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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