Skip to main content
. 2016 Jul 5;2016(7):CD003839. doi: 10.1002/14651858.CD003839.pub3

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).
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.
Outcomes Primary outcomes: percentage of INR values within target range; time within target range.
Secondary outcomes: major thromboembolic or haemorrhagic complications; minor bleeding; death.
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.