Comparison Between Conventional Anticoagulation Treatment and Self-management of Anticoagulation Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Bergen
- Enrollment
- 130
- Primary Endpoint
- Change in Time in therapeutic range (TTR)
Study Overview
Brief Summary
The aim of the study was to compare self-management of anticoagulant treatment with conventional anticoagulant treatment in Norway.
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Conventional treatment
Conventional anticoagulation treatment Before enrolment
Self-management
Trained to monitor INR and dose warfarin
Intervention: Training (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change in number of complications(From two years before enrolment until two years of self management)
- Quality of life (QoL)(Baseline before training and after two years with self-management)
Investigators
Una Ørvim Sølvik
Associate Professor
University of Bergen