Self-management of Anticoagulation Treatment

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02864537

Enrollment

130

Registered

2016-08-12

Start date

2009-01-31

Completion date

2013-03-31

Last updated

2016-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Heart Valve, Atrial Fibrillation, Venous Thromboembolism

Keywords

warfarin, self-management, Conventional management, Training, TTR, Complications, Quality of life

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.

Interventions

OTHERTraining

Patients were trained to measure INR and dose warfarin

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Time in therapeutic range (TTR)	From two years before enrolment until two years of self management	Change in TTR from conventional treatment to self-management

Secondary

Measure	Time frame	Description
Change in number of complications	From two years before enrolment until two years of self management	Compare number of complications during conventional treatment and during self-management
Quality of life (QoL)	Baseline before training and after two years with self-management	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026