Siebenhofer 2007.
| Study characteristics | ||
| Methods | Multicentre, randomised controlled trial. | |
| Participants | Participants (n = 195) were adults aged > 60 (mean 69) years, with an indication for long‐term oral anticoagulation. Exclusion criteria included: previous participation in an anticoagulation self‐management program; severe cognitive or terminal illness. The study was based in 3 departments specialising in the treatment of participants receiving long‐term oral anticoagulation therapy (Austria). |
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| Interventions |
Self‐management vs usual care Participants were randomised to a) self‐management (n = 99): home self‐testing using the Coagucheck® and self‐dosing. INR testing performed once a week, adjusting anticoagulant dosage accordingly. Participants were asked to contact the training centre in case of difficulties. b) usual care (n = 96): anticoagulant dosage adjusted by usual attending physicians in general practice or at a hospital based specialised anticoagulation clinic. |
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| Outcomes | Primary outcome: composite of all thromboembolic events requiring hospitalisation and all major bleeding complications. Secondary outcomes: frequency and duration of hospitalisation; mortality; recurrence of stroke; numbers of INR values above 4.5 or lower than 1.7; treatment‐related quality of life; cost‐effectiveness. |
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| Trial identification | ||
| Study duration | 12 months | |
| Oral anticoagulant used | Phenprocoumon (90% participants), acenocoumarol (10% participants) | |
| Notes | Participants assigned to the self‐management group participated in four consecutive weekly instruction sessions of 90 to 120 minutes each, in groups of three to six participants. Participants assigned to the control group participated in a single 90‐miute session including basic theoretical information. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐based system. |
| Allocation concealment (selection bias) | Low risk | Allocation was done by a central statistical office by fax and without awareness of participant data. The sequence of randomisation was concealed until the participant was assigned to a group. |
| Intention to treat analysis | Unclear risk | ITT analysis was used for primary outcome; per protocol analyses used for other outcomes |
| Reporting of losses of follow‐up | Low risk | 19/195 (9.7%) participants lost to follow‐up; reasons reported |
| Blinding | Low risk | Blinded outcome assessors. |