Self-management of Anticoagulation Treatment

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864537
• Other study ID #: Lokkebo
• Status: Completed
• Phase: N/A
• First received: August 9, 2016
• Last updated: August 9, 2016
• Start date: January 2009
• Est. completion date: March 2013

Study information

• Verified date: August 2016
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Artificial Heart Valve
• Atrial Fibrillation
• Thromboembolism
• Venous Thromboembolism

Intervention

Other:
• Training
Patients were trained to measure INR and dose warfarin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Bergen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Time in therapeutic range (TTR)	Change in TTR from conventional treatment to self-management	From two years before enrolment until two years of self management	No
Secondary	Change in number of complications	Compare number of complications during conventional treatment and during self-management	From two years before enrolment until two years of self management	No
Secondary	Quality of life (QoL)		Baseline before training and after two years with self-management	No