Clinical trial NCT00560911: Major Outcomes in Elderly Patients With Self-Management of Oral Anticoagulation (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+
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Long-Term Oral Anticoagulated Patients
Keywords: oral anticoagulation
self-management
elderly patients
randomised controlled trial
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Boehringer Mannheim
First posted: 2007-11-20
Enrollment: 216
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications
timeFrame: during the time of follow up (at least two years)
Secondary outcomes:
measure: frequency and duration of hospitalisation
timeFrame: during the time of follow up (at least two years)
measure: mortality
timeFrame: during the time of follow up (at least two years)
measure: recurrence of stroke
timeFrame: during the time of follow up (at least two years)
measure: numbers of INR values above 4.5 or lower than 1.7
timeFrame: during the time of follow up (at least two years)
measure: treatment-related quality of life analysis
timeFrame: during the time of follow up (at least two years)
measure: cost-effectiveness evaluations
timeFrame: during the time of follow up (at least two years)
measure: median of squared INR value deviation (INR - ½(Upper Value of Target INR Range + Lower Value of Target INR Range))
timeFrame: during the time of follow up (at least two years)
measure: percentage of individual patients' INR values within the target range and the percentage of time within target range
timeFrame: during the time of follow up (at least two years)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Cologne
country: Germany
facility: DIeM - Institute for Evidence-based Medicine
Study officials:
affiliation: DIeM - Institute for Evidence-based Medicine, Cologne, Germany
name: Ulrike Didjurgeit, psychologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, Medical University of Graz, Austria
name: Andrea Siebenhofer, consultant
role: STUDY_CHAIR
References:
citation: 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.