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Self-management of Anticoagulation Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02864537
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : August 12, 2016
Information provided by (Responsible Party):
Una Ørvim Sølvik, University of Bergen

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Venous Thromboembolism Artificial Heart Valve Other: Training Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Conventional Anticoagulation Treatment and Self-management of Anticoagulation Treatment
Study Start Date : January 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
No Intervention: Conventional treatment
Conventional anticoagulation treatment Before enrolment
Experimental: Self-management
Trained to monitor INR and dose warfarin
Other: Training
Patients were trained to measure INR and dose warfarin

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02864537

Sponsors and Collaborators
University of Bergen
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Principal Investigator: Una Ø Sølvik, PhD University of Bergen

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Responsible Party: Una Ørvim Sølvik, Associate Professor, University of Bergen Identifier: NCT02864537    
Other Study ID Numbers: Lokkebo
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Una Ørvim Sølvik, University of Bergen:
Conventional management
Quality of life
Additional relevant MeSH terms:
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Atrial Fibrillation
Venous Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases