Menendez‐Jandula 2005.
Study characteristics | ||
Methods | Single centre, randomised controlled trial. | |
Participants | Participants (n=737) were ambulatory adults aged > 18 (mean 66) years, receiving long‐term anticoagulation therapy for > before the study for at least 3 months. The study was based in a University Hospital (Barcelona, Spain). |
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Interventions |
Self‐management vs usual care Participants were randomised to: a) self‐management (n = 368): home self‐testing using the Coagucheck® ,self‐adjustment of dosage of oral anticoagulant, and self‐determination of time to next INR test. b) usual care (n = 369): visited the hospital for every four weeks to have their INR checked. |
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Outcomes | Primary outcomes: percentage of INR values within target range; time within target range. Secondary outcomes: major thromboembolic or haemorrhagic complications; minor bleeding; death. |
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Trial identification | ACOA | |
Study duration | Up to 17 months | |
Oral anticoagulant used | Warfarin or acenocoumarol | |
Notes | Training: two 2‐hour sessions in consecutive days run by a trained nurse. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Centralised telephone randomisation. |
Allocation concealment (selection bias) | Low risk | The sequence of randomisation was concealed until the participant was assigned to a group. |
Intention to treat analysis | Low risk | ITT analysis was used |
Reporting of losses of follow‐up | Unclear risk | 11.9% of participants were lost to follow‐up; reasons not reported. |
Blinding | Low risk | Blinded outcome assessors. |