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

NCT ID: NCT00560911

Last Updated: 2007-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2007-02-28

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.

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.

Conditions

Long-Term Oral Anticoagulated Patients

Keywords

oral anticoagulation; self-management; elderly patients; randomised controlled trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1Self-management

Group Type: OTHER

educational program for the self-management of OAC

Intervention Type: BEHAVIORAL

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.

2 Routine control

Group Type: OTHER

1 hour education - afterwards physician leaded OAC control

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Mannheim

INDUSTRY

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: lead

Principal Investigators

Ulrike Didjurgeit, psychologist

Role: PRINCIPAL_INVESTIGATOR

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

Andrea Siebenhofer, consultant

Role: STUDY_CHAIR

Department of Internal Medicine, Medical University of Graz, Austria

Locations

Medical University Graz

Graz, Styria, Austria

Medical University of Vienna

Vienna, , Austria

DIeM - Institute for Evidence-based Medicine

Cologne, , Germany

Countries

Austria; Germany

References

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.

Reference Type: RESULT

PMID: 17334508 (View on PubMed)

Other Identifiers

SPOG60+

Identifier Type: -

Identifier Source: org_study_id