Self-management of Anticoagulation Treatment

August 9, 2016 updated by: Una Ørvim Sølvik, University of Bergen

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=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.

Study Type

Interventional

Enrollment (Actual)

130

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
  • 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

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: From two years before enrolment until two years of self management
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)
Time Frame: Baseline before training and after two years with self-management
Baseline before training and after two years with self-management

Collaborators and Investigators

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

Sponsor

University of Bergen

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

January 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lokkebo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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