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

This study has been completed.
Sponsor:
Collaborator:
Boehringer Mannheim
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00560911
First received: November 17, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Long-Term Oral Anticoagulated Patients
 Behavioral: educational program for the self-management of OAC
Behavioral: 1 hour education - afterwards physician leaded OAC control
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Self-Management of Oral Anticoagulation in the Elderly in Terms of Mortality and Morbidity: a Randomized Controlled Trial - SPOG 60+

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • frequency and duration of hospitalisation [ Time Frame: during the time of follow up (at least two years) ]
  • mortality [ Time Frame: 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) ]
  • numbers of INR values above 4.5 or lower than 1.7 [ Time Frame: 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) ]
  • cost-effectiveness evaluations [ Time Frame: 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) ]
  • 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) ]

Enrollment: 216
Study Start Date: March 2002
Study Completion Date: February 2007
Arms Assigned Interventions
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 Name: n.a.
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.

Other Name: n.a.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560911

Locations
Austria
Medical University Graz
Graz, Styria, Austria, 8036
Medical University of Vienna
Vienna, Austria, 1090
Germany
DIeM - Institute for Evidence-based Medicine
Cologne, Germany, 50823
Sponsors and Collaborators
Medical University of Graz
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
  More Information

Additional Information:
EBM Review Center of the Medical University Graz  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00560911     History of Changes
Other Study ID Numbers: SPOG60+
Study First Received: November 17, 2007
Last Updated: November 17, 2007
Health Authority: Austria: Ethikkommission
Germany: Ethics Commission
Switzerland: Ethikkommission

Keywords provided by Medical University of Graz:
oral anticoagulation
self-management
elderly patients
randomised controlled trial

ClinicalTrials.gov processed this record on May 21, 2013