NCT02864537

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable atrial-fibrillation

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

4.2 years

First QC Date

August 9, 2016

Last Update Submit

August 9, 2016

Conditions

Atrial FibrillationVenous ThromboembolismArtificial Heart Valve

Keywords

warfarinself-managementConventional managementTrainingTTRComplicationsQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

Study Arms (2)

Conventional treatment

NO INTERVENTION

Conventional anticoagulation treatment Before enrolment

Self-management

EXPERIMENTAL

Trained to monitor INR and dose warfarin

Other: Training

Interventions

TrainingOTHER

Patients were trained to measure INR and dose warfarin

Self-management

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Drug abuse
  • Liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial FibrillationVenous Thromboembolism

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsThromboembolismEmbolism and ThrombosisVascular Diseases

Study Officials

  • Una Ø Sølvik, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 12, 2016

Study Start

January 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

August 12, 2016

Record last verified: 2016-08