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

November 17, 2007 updated by: Medical University of Graz

Impact of Self-Management of Oral Anticoagulation in the Elderly in Terms of Mortality and Morbidity: a Randomized Controlled Trial - SPOG 60+

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Oral anticoagulation (OAC) has been shown to be highly effective in preventing thromboembolic complications in patients for whom it is indicated. Numerous studies have documented that elderly patients seem to benefit most from OAC therapy. Atrial fibrillation (AF), the incidence of which increases with age and approaches 10% for individuals aged ≥ 80 years, carries the main risk for stroke, and among elderly patients without antithrombotic therapy,

Despite its proven benefit, numerous studies have reported reluctance in prescribing OAC due to a variety of barriers, especially in the elderly. Risk of haemorrhage, which is in fact twice as great in those over 70 years of age as in younger patients, is one of the major determinants of refusal to prescribe OAC therapy. The risk of stroke rises steeply in patients with atrial fibrillation when INR values are less than 1.8 and INR values greater than 4 to 5 are rapidly associated with increased bleeding rates. Due to relatively small therapeutic ranges, the reality is often that only a small percentage of the INR values have been found to be within the target range, which can be low as 29% of INR measurements, as seen in routine care patients prior to participation in a randomised self-management programme study.

One way to improve OAC care is by introducing patients' self-management of OAC therapy. In this context it is important to differentiate between INR self-testing alone, and full self-management. Self-management includes self-adaptation of the anticoagulation treatment based on self-monitoring results after the patients have participated in a structured instruction and treatment programme.

Our study aims to provide answers to this important medical question by examining elderly patients receiving long-term anticoagulation treatment and randomised into self-management versus routine-care groups, with thromboembolic and haemorrhagic complications as primary outcomes.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna
    • Styria
      • Graz, Styria, Austria, 8036
        • Medical University Graz
  • Germany
      • Cologne, Germany, 50823
        • DIeM - Institute for Evidence-based Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1Self-management
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.
Other: 2 Routine control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications
Time Frame: during the time of follow up (at least two years)
during the time of follow up (at least two years)

Secondary Outcome Measures

Outcome Measure
Time Frame
frequency and duration of hospitalisation
Time Frame: during the time of follow up (at least two years)
during the time of follow up (at least two years)
mortality
Time Frame: during the time of follow up (at least two years)
during the time of follow up (at least two years)
recurrence of stroke
Time Frame: during the time of follow up (at least two years)
during the time of follow up (at least two years)
numbers of INR values above 4.5 or lower than 1.7
Time Frame: during the time of follow up (at least two years)
during the time of follow up (at least two years)
treatment-related quality of life analysis
Time Frame: during the time of follow up (at least two years)
during the time of follow up (at least two years)
cost-effectiveness evaluations
Time Frame: during the time of follow up (at least two years)
during the time of follow up (at least two years)
median of squared INR value deviation (INR - ½(Upper Value of Target INR Range + Lower Value of Target INR Range))
Time Frame: during the time of follow up (at least two years)
during the time of follow up (at least two years)
percentage of individual patients' INR values within the target range and the percentage of time within target range
Time Frame: during the time of follow up (at least two years)
during the time of follow up (at least two years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Boehringer Mannheim

Investigators

  • Principal Investigator: Ulrike Didjurgeit, psychologist, DIeM - Institute for Evidence-based Medicine, Cologne, Germany
  • Study Chair: Andrea Siebenhofer, consultant, Department of Internal Medicine, Medical University of Graz, Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

November 17, 2007

First Submitted That Met QC Criteria

November 17, 2007

First Posted (Estimate)

November 20, 2007

Study Record Updates

Last Update Posted (Estimate)

November 20, 2007

Last Update Submitted That Met QC Criteria

November 17, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SPOG60+

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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