Self-management of Anticoagulation Treatment | NCT02371772

Studies
Self-management of Anticoagulation Treatment

NCT02371772

Sponsor

Una Ørvim Sølvik

Status

Completed

Last Update Posted

Feb 26, 2015Estimated

Enrollment

23Actual

Phase

Not Applicable

Conditions

Long-term Oral Anticoagulant Therapy

Interventions

Training

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Feb 11, 2015

First Submission Date that Met QC Criteria

Feb 19, 2015

First Posted Date

Feb 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2015

Last Update Posted Date

Feb 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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=23) on anticoagulant treatment with warfarin participated in a 27 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 28 weeks. 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. Ten INR values and complications 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 28 weeks of self-management.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Self-management anticoagulation treatment	Other	Trained to monitor INR and dose warfarin	Other: Training
Conventional anticoagulation treatment	No Intervention	Before enrolment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Training	Other	Patients were trained to monitor INR and dose warfarin	Self-management anticoagulation treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Time in therapeutic range (TTR)		From 39 weeks before enrolment until 28 weeks of self management

Secondary Outcomes

Measure	Description	Time Frame
Change in number of complications		From 39 weeks before enrolment until 28 weeks of self management

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Drug abuse
Liver disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Una Ø Sølvik, PhD	University of Bergen	Principal Investigator

Locations

Not provided