Self-management of Anticoagulation Treatment

Long-term Oral Anticoagulant Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371772
• Other study ID #: UBergen
• Status: Completed
• Phase: N/A
• First received: February 11, 2015
• Last updated: February 19, 2015
• Start date: August 2008
• Est. completion date: September 2009

Study information

• Verified date: February 2015
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Directorate of Health
• 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=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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Long-term Oral Anticoagulant Therapy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Una Ørvim Sølvik

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Time in therapeutic range (TTR)		From 39 weeks before enrolment until 28 weeks of self management	No
Secondary	Change in number of complications		From 39 weeks before enrolment until 28 weeks of self management	No