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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: NCT02371772
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
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
Long-term Oral Anticoagulant Therapy Other: Training Not Applicable

Detailed Description:
Patients (n=23) on anticoagulant treatment with warfarin participated in a 27 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 28 weeks. 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. Ten INR values and complications 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 28 weeks of self-management.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Comparison Between Conventional Anticoagulation Treatment and Self-management of Anticoagulation Treatment
Study Start Date : August 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Self-management anticoagulation treatment
Trained to monitor INR and dose warfarin
Other: Training
Patients were trained to monitor INR and dose warfarin

No Intervention: Conventional anticoagulation treatment
Before enrolment

Primary Outcome Measures :
  1. Change in Time in therapeutic range (TTR) [ Time Frame: From 39 weeks before enrolment until 28 weeks of self management ]

Secondary Outcome Measures :
  1. Change in number of complications [ Time Frame: From 39 weeks before enrolment until 28 weeks of self management ]

Information from the National Library of Medicine

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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
  • Live in Bergen municipality
  • 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): NCT02371772

Sponsors and Collaborators
Una Ørvim Sølvik
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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: NCT02371772    
Other Study ID Numbers: UBergen
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015
Keywords provided by Una Ørvim Sølvik, University of Bergen:
Self Care
Conventional care