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Major Outcomes in Elderly Patients With Self-Management of Oral Anticoagulation (SPOG60+)

NCT00560911 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2007-11-20

No results posted yet for this study

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.

Conditions

  • Long-Term Oral Anticoagulated Patients

Interventions

BEHAVIORAL

educational program for the self-management of OAC

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.

BEHAVIORAL

1 hour education - afterwards physician leaded OAC control

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.

Sponsors & Collaborators

  • Boehringer Mannheim

    collaborator INDUSTRY

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Ulrike Didjurgeit, psychologist · DIeM - Institute for Evidence-based Medicine, Cologne, Germany

  • Andrea Siebenhofer, consultant · Department of Internal Medicine, Medical University of Graz, Austria

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Completion
2007-02-28

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00560911 on ClinicalTrials.gov