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Self-management of Anticoagulation Treatment

Primary Purpose

Atrial Fibrillation, Venous Thromboembolism, Artificial Heart Valve

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Training
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring warfarin, self-management, Conventional management, Training, TTR, Complications, Quality of life

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Conventional treatment

    Self-management

    Arm Description

    Conventional anticoagulation treatment Before enrolment

    Trained to monitor INR and dose warfarin

    Outcomes

    Primary Outcome Measures

    Change in Time in therapeutic range (TTR)
    Change in TTR from conventional treatment to self-management

    Secondary Outcome Measures

    Change in number of complications
    Compare number of complications during conventional treatment and during self-management
    Quality of life (QoL)

    Full Information

    First Posted
    August 9, 2016
    Last Updated
    August 9, 2016
    Sponsor
    University of Bergen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02864537
    Brief Title
    Self-management of Anticoagulation Treatment
    Official Title
    Comparison Between Conventional Anticoagulation Treatment and Self-management of Anticoagulation Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Bergen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation, Venous Thromboembolism, Artificial Heart Valve
    Keywords
    warfarin, self-management, Conventional management, Training, TTR, Complications, Quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional treatment
    Arm Type
    No Intervention
    Arm Description
    Conventional anticoagulation treatment Before enrolment
    Arm Title
    Self-management
    Arm Type
    Experimental
    Arm Description
    Trained to monitor INR and dose warfarin
    Intervention Type
    Other
    Intervention Name(s)
    Training
    Intervention Description
    Patients were trained to measure INR and dose warfarin
    Primary Outcome Measure Information:
    Title
    Change in Time in therapeutic range (TTR)
    Description
    Change in TTR from conventional treatment to self-management
    Time Frame
    From two years before enrolment until two years of self management
    Secondary Outcome Measure Information:
    Title
    Change in number of complications
    Description
    Compare number of complications during conventional treatment and during self-management
    Time Frame
    From two years before enrolment until two years of self management
    Title
    Quality of life (QoL)
    Time Frame
    Baseline before training and after two years with self-management

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Una Ø Sølvik, PhD
    Organizational Affiliation
    University of Bergen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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