Long-Term Oral Anticoagulated PatientsPhase 4SPOG60+NCT00560911
Major Outcomes in Elderly Patients With Self-Management of Oral Anticoagulation (SPOG60+)
A Phase 4 study testing educational program for the self-management of OAC in people with Long-Term Oral Anticoagulated Patients, run by Medical University of Graz at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Long-Term Oral Anticoagulated Patients
- What is being tested?
- educational program for the self-management of OAC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2002to Feb 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- long-term anticoagulation
- either with phenprocoumon or acenocoumarol
- age ≥ 60 years
- written informed consent
Who cannot join
- previous participation in a self-management OAC programme
- severe cognitive
- terminal illness
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Austria2 sites
Medical University Graz
Graz, Styria, 8036
Medical University of Vienna
Vienna, 1090
About this study
Official title: 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.
Read the 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
- Being tested
- educational program for the self-management of OAC, 1 hour education - afterwards physician leaded OAC control
- Keywords
- oral anticoagulation, self-management, elderly patients, randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational program for the self-management of OACBehavioural
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 controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1Self-management | Other | Not described Receives: Behavioral: educational program for the self-management of OAC |
| 2 Routine control | Other | Not described Receives: Behavioral: 1 hour education - afterwards physician leaded OAC control |
What is being measured
The primary outcome is the main question the study is designed to answer.
combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications
Measured: during the time of follow up (at least two years)
Secondary outcomes (8)
frequency and duration of hospitalisation
Measured: during the time of follow up (at least two years)
mortality
Measured: during the time of follow up (at least two years)
recurrence of stroke
Measured: during the time of follow up (at least two years)
numbers of INR values above 4.5 or lower than 1.7
Measured: during the time of follow up (at least two years)
treatment-related quality of life analysis
Measured: during the time of follow up (at least two years)
cost-effectiveness evaluations
Measured: 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))
Measured: 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
Measured: during the time of follow up (at least two years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startMar 2002
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long-Term Oral Anticoagulated PatientsStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Mannheim
- Investigators
- Ulrike Didjurgeit, psychologist, Principal investigator, DIeM - Institute for Evidence-based Medicine, Cologne, GermanyAndrea Siebenhofer, consultant, Study chair, Department of Internal Medicine, Medical University of Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560911
- Sponsor's protocol ID
- SPOG60+
- Acronym
- SPOG60+
- Status last verified
- Nov 2007
- First submitted
- 17 Nov 2007
- Last updated
- 20 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17334508
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Self-Management of Oral Anticoagulation in the Elderly in Terms of Mortality and Morbidity: a Randomized Controlled Trial - SPOG 60+
- ClinicalTrials.gov ID
- NCT00560911
- Acronym / sponsor ID
- SPOG60+ / SPOG60+
- Conditions
- Long-Term Oral Anticoagulated Patients
- Keywords
- oral anticoagulation, self-management, elderly patients, randomised controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Boehringer Mannheim
- Study start
- Mar 2002
- Study completion
- Feb 2007 (actual)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1Self-management | Other | Behavioral: educational program for the self-management of OAC |
| 2 Routine control | Other | Behavioral: 1 hour education - afterwards physician leaded OAC control |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- long-term anticoagulation
- either with phenprocoumon or acenocoumarol
- age ≥ 60 years
- written informed consent
Key exclusion criteria (3 listed)
- previous participation in a self-management OAC programme
- severe cognitive
- terminal illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational program for the self-management of OACPatients 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. | Behavioural | 1Self-management |
| 1 hour education - afterwards physician leaded OAC controlPatients 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. | Behavioural | 2 Routine control |
Primary outcome
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)
8 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2007.
- Results publication: PubMed 17334508Siebenhofer 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Didjurgeit, psychologist principal investigator
DIeM - Institute for Evidence-based Medicine, Cologne, Germany
Andrea Siebenhofer, consultant study chair
Department of Internal Medicine, Medical University of Graz, Austria
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing educational program for the self-management of OAC in people with Long-Term Oral Anticoagulated Patients, run by Medical University of Graz at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00560911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2007.