NCT02371772

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
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

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

August 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

February 11, 2015

Last Update Submit

February 19, 2015

Conditions

Long-term Oral Anticoagulant Therapy

Keywords

WarfarinSelf CareConventional care

Outcome Measures

Primary Outcomes (1)

  • Change in Time in therapeutic range (TTR)

    From 39 weeks before enrolment until 28 weeks of self management

Secondary Outcomes (1)

  • Change in number of complications

    From 39 weeks before enrolment until 28 weeks of self management

Study Arms (2)

Self-management anticoagulation treatment

OTHER

Trained to monitor INR and dose warfarin

Other: Training

Conventional anticoagulation treatment

NO INTERVENTION

Before enrolment

Interventions

TrainingOTHER

Patients were trained to monitor INR and dose warfarin

Self-management anticoagulation treatment

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
  • Live in Bergen municipality
  • 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

Study Officials

  • Una Ø Sølvik, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 11, 2015

First Posted

February 26, 2015

Study Start

August 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

February 26, 2015

Record last verified: 2015-02