NCT00560911

Brief Summary

Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC). However, no study has yet assessed the safety and efficacy of OAC self-management in elderly patients with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre, open, randomised controlled trial, patients aged 60 years or will be randomised into a self-management or routine care group and followed up for at least two years. The primary hypothesis of the study is that self-management of oral anticoagulation is superior compared to routine control in terms of reducing thromboembolic events requiring hospitalisation and all major bleeding complications as the primary endpoint.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_4

Geographic Reach
2 countries

3 active sites

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

March 1, 2002

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
Last Updated

November 20, 2007

Status Verified

November 1, 2007

First QC Date

November 17, 2007

Last Update Submit

November 17, 2007

Conditions

Long-Term Oral Anticoagulated Patients

Keywords

oral anticoagulationself-managementelderly patientsrandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications

    during the time of follow up (at least two years)

Secondary Outcomes (8)

  • frequency and duration of hospitalisation

    during the time of follow up (at least two years)

  • mortality

    during the time of follow up (at least two years)

  • recurrence of stroke

    during the time of follow up (at least two years)

  • numbers of INR values above 4.5 or lower than 1.7

    during the time of follow up (at least two years)

  • treatment-related quality of life analysis

    during the time of follow up (at least two years)

  • +3 more secondary outcomes

Study Arms (2)

1Self-management

OTHER
Behavioral: educational program for the self-management of OAC

2 Routine control

OTHER
Behavioral: 1 hour education - afterwards physician leaded OAC control

Interventions

educational program for the self-management of OACBEHAVIORAL

Patients in the self-management group participated in 4 consecutive weekly instruction sessions of 90 to 120 minutes each, in groups of 3 to 6 patients. After participation in the structured programme, the patients were encouraged to control their INR values by self-monitoring once a week and to adjust their anticoagulant dosage accordingly.

1Self-management
1 hour education - afterwards physician leaded OAC controlBEHAVIORAL

Patients in the routine control group participated a single 90-minute session During the whole study period, they were advised with regard to changes in the anticoagulant dosage by their usual attending physicians, either in general practice or at a hospital-based specialised anticoagulation clinic.

2 Routine control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • long-term anticoagulation
  • either with phenprocoumon or acenocoumarol
  • age ≥ 60 years
  • written informed consent

You may not qualify if:

  • previous participation in a self-management OAC programme
  • severe cognitive
  • terminal illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medical University Graz

Graz, Styria, 8036, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

DIeM - Institute for Evidence-based Medicine

Cologne, 50823, Germany

Location

Related Publications (1)

  • Siebenhofer A, Rakovac I, Kleespies C, Piso B, Didjurgeit U. Self-management of oral anticoagulation in the elderly: rationale, design, baselines and oral anticoagulation control after one year of follow-up. A randomized controlled trial. Thromb Haemost. 2007 Mar;97(3):408-16.

    PMID: 17334508RESULT

Study Officials

  • Ulrike Didjurgeit, psychologist

    DIeM - Institute for Evidence-based Medicine, Cologne, Germany

    PRINCIPAL INVESTIGATOR

  • Andrea Siebenhofer, consultant

    Department of Internal Medicine, Medical University of Graz, Austria

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2007

First Posted

November 20, 2007

Study Start

March 1, 2002

Study Completion

February 1, 2007

Last Updated

November 20, 2007

Record last verified: 2007-11

Locations

DE(1)AU(2)