title: 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.
abstract: 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 more were randomised into the self-management group (SMG) (N = 99) or routine care group (RCG) (N = 96). We describe the rationale, design, baseline characteristics and interim analyses of oral anticoagulation control quality within the first year of follow-up. The medians of the squared international normalised ratio (INR) value deviations after six and 12 months were significantly lower in the SMG with medians of 0.16 and 0.16 compared to the RCG with medians of 0.25 and 0.25. The percentage of time within target range and the percentage of INR measurements within target range were significantly higher in the SMG versus the RCG within the first six months (medians 71% vs. 58% and 69% vs. 57%), and during the second six months of the study (75% vs. 67% and 72% vs. 57%). The numbers of all thromboembolic events requiring hospitalisation, major bleeding events, and deaths were similar in both groups. These preliminary results suggest that self-management of oral anticoagulation is safe and feasible for elderly patients willing to participate in a structured training programme.
authors.affiliation: 1Department of Internal Medicine, Medical University of Graz, Graz, Austria. andrea.siebenhofer@meduni-graz.at
authors.forename: Andrea
authors.initials: A
authors.lastname: Siebenhofer
authors.forename: Ivo
authors.initials: I
authors.lastname: Rakovac
authors.forename: Caroline
authors.initials: C
authors.lastname: Kleespies
authors.forename: Brigitte
authors.initials: B
authors.lastname: Piso
authors.forename: Ulrike
authors.initials: U
authors.lastname: Didjurgeit
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001317:Austria; D001777:Blood Coagulation / Q000187:drug effects*; D016903:Drug Monitoring / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D007722:Health Knowledge, Attitudes, Practice; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic; D015397:Program Evaluation; D012107:Research Design; D012648:Self Care; D013923:Thromboembolism / Q000517:prevention & control*; D013997:Time Factors
chemical_list: D000925:Anticoagulants