Self-management of Anticoagulation Treatment

NCT ID: NCT02864537

Last Updated: 2016-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation Venous Thromboembolism Artificial Heart Valve

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional treatment

Conventional anticoagulation treatment Before enrolment

Group Type NO_INTERVENTION

No interventions assigned to this group

Self-management

Trained to monitor INR and dose warfarin

Group Type EXPERIMENTAL

Training

Intervention Type OTHER

Patients were trained to measure INR and dose warfarin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Training

Patients were trained to measure INR and dose warfarin

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Una Ørvim Sølvik

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Una Ø Sølvik, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Lokkebo

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Anticoagulation Medical Home
NCT02870296 COMPLETED NA
Recanalization Rate of Acute DVT
NCT06145269 NOT_YET_RECRUITING EARLY_PHASE1
Protocol for Improvement of Therapy With Warfarin
NCT06789588 ENROLLING_BY_INVITATION PHASE3