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

Long-Term Oral Anticoagulated Patients Clinical Trial

— SPOG60+  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560911
• Other study ID #: SPOG60+
• Status: Completed
• Phase: Phase 4
• First received: November 17, 2007
• Last updated: November 17, 2007
• Start date: March 2002
• Est. completion date: February 2007

Study information

• Verified date: November 2007
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionGermany: Ethics CommissionSwitzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Long-Term Oral Anticoagulated Patients

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz	Styria
Austria	Medical University of Vienna	Vienna
Germany	DIeM - Institute for Evidence-based Medicine	Cologne

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Boehringer Mannheim

Countries where clinical trial is conducted

Austria,  Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications		during the time of follow up (at least two years)
Secondary	frequency and duration of hospitalisation		during the time of follow up (at least two years)
Secondary	mortality		during the time of follow up (at least two years)
Secondary	recurrence of stroke		during the time of follow up (at least two years)
Secondary	numbers of INR values above 4.5 or lower than 1.7		during the time of follow up (at least two years)
Secondary	treatment-related quality of life analysis		during the time of follow up (at least two years)
Secondary	cost-effectiveness evaluations		during the time of follow up (at least two years)
Secondary	median of squared INR value deviation (INR - ½(Upper Value of Target INR Range + Lower Value of Target INR Range))		during the time of follow up (at least two years)
Secondary	percentage of individual patients' INR values within the target range and the percentage of time within target range		during the time of follow up (at least two years)