Abstract Background Management of intermittent claudication should include secondary prevention to reduce the risk of cardiocerebrovascular disease. Patient adherence to secondary prevention is a challenge. The aim of this study was to investigate whether a person-centred, nurse-led follow-up programme could improve adherence to medication compared with standard care. Methods A non-blinded RCT was conducted at two vascular surgery centres in Sweden. Patients with intermittent claudication and scheduled for revascularization were randomized to the intervention or control (standard care) follow-up programme. The primary outcome, adherence to prescribed secondary preventive medication, was based on registry data on dispensed medication and self-reported intake of medication. Secondary outcomes were risk factors for cardiocerebrovascular disease according to the Framingham risk score. Results Some 214 patients were randomized and analysed on an intention-to-treat basis. The mean proportion of days covered (PDC) at 1 year for lipid-modifying agents was 79 per cent in the intervention and 82 per cent in the control group, whereas it was 92 versus 91 per cent for antiplatelet and/or anticoagulant agents. The groups did not differ in mean PDC (lipid-modifying P = 0.464; antiplatelets and/or anticoagulants P = 0.700) or in change in adherence over time. Self-reported adherence to prescribed medication was higher than registry-based adherence regardless of allocation or medication group (minimum P < 0.001, maximum P = 0.034). There was no difference in median Framingham risk score at 1 year between the groups. Conclusion Compared with the standard follow-up programme, a person-centred, nurse-led follow-up programme did not improve adherence to secondary preventive medication. Adherence was overestimated when self-reported compared with registry-reported.

中文翻译：

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以人为本、护士主导的随访计划对接受手术治疗间歇性跛行的患者遵守处方药物的影响：随机临床试验

摘要 背景间歇性跛行的治疗应包括二级预防，以降低心脑血管疾病的风险。患者坚持二级预防是一个挑战。本研究的目的是调查与标准护理相比，以人为本、护士主导的随访计划是否可以提高药物依从性。 方法在瑞典的两个血管外科中心进行了一项非盲法随机对照试验。患有间歇性跛行并计划进行血运重建的患者被随机分配至干预或对照（标准护理）随访计划。主要结果是遵守规定的二级预防药物，这是基于配发药物和自我报告的药物摄入量的登记数据。次要结果是根据弗雷明汉风险评分的心脑血管疾病的危险因素。 结果大约 214 名患者被随机分组​​并在意向治疗的基础上进行分析。1 年时调脂药物的平均覆盖天数 (PDC) 干预组为 79%，对照组为 82%，而抗血小板和/或抗凝药物的平均覆盖天数比例 (PDC) 为 92% 和 91%。各组在平均 PDC（脂质修饰 P = 0.464；抗血小板和/或抗凝剂 P = 0.700）或依从性随时间的变化方面没有差异。无论分配或药物组如何，自我报告的处方药物依从性均高于基于登记的依从性（最小 P < 0.001，最大 P = 0.034）。各组之间 1 年时弗雷明汉风险评分中位数没有差异。 结论与标准随访计划相比，以人为本、护士主导的随访计划并没有提高二级预防药物的依从性。与登记报告相比，自我报告的依从性被高估了。