Self-management of Anticoagulation Treatment

February 19, 2015 updated by: Una Ørvim Sølvik

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Time in therapeutic range (TTR)
Time Frame: From 39 weeks before enrolment until 28 weeks of self management
From 39 weeks before enrolment until 28 weeks of self management

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in number of complications
Time Frame: From 39 weeks before enrolment until 28 weeks of self management
From 39 weeks before enrolment until 28 weeks of self management

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Una Ørvim Sølvik

Investigators

  • Principal Investigator: Una Ø Sølvik, PhD, University of Bergen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Estimate)

February 26, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UBergen

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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