Management of intermittent claudication (IC) should include secondary prevention to reduce the increased risk of cardiocerebrovascular diseases. Patients' non-adherence to secondary prevention is a challenge and person-centred care has been suggested to ameliorate this. This randomised controlled trial aimed to investigate the effects of a person-centred, nurse-led follow-up program among patients surgically treated for intermittent claudication compared to standard care. Our hypothesis was that the intervention program would improve patients' adherence to prescribed medication.

Patients with IC scheduled for revascularization at the two vascular surgery centres in Stockholm, Sweden was recruited between 2016 - 2018 and randomised to intervention or control. No blinding was applied. During the follow-up year after surgery, patients in the intervention group received person-centred care during three visits and two telephone calls with a vascular nurse while patients in the control group received two visits to a vascular surgeon or vascular nurse. The person-centered care model used was developed at the University of Gothenburg, comprising 1) the establishment of a partnership between the professional health care worker and the patient; 2) patient narratives; and 3) a documented self-care plan comprising goals, self-care activities, and plan for future follow-up and revision. The primary outcome, adherence to prescribed lipid-modifying agents and antiplatelets and/or anticoagulants, was assessed according to registry data on dispensed medication and self-reported data. Adherence was calculated and presented as Proportion of Days Covered (PDC). Secondary outcomes were risk factors of cardiocerebrovascular diseased assessed individually and according to Framingham risk score.

A total of 214 patients were randomised to intervention group (107) or control group (107); 99 in the intervention group and 105 in the control group were analysed according to intent to treat. Average adherence (PDC) at one year for lipid-modifying agents was 79% in the intervention group and 82% in the control group while it was 92% vs 91% for antiplatelets and/or anticoagulants. There were no differences between the groups neither 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 when compared with registry-reported adherence regardless of allocation or medication group (min P < 0.001, max P = 0.034). There was no difference in median Framingham risk score at one year between the groups. For the entire cohort, those who had quit smoking less than 6 months before surgery relapsed to smoking to a higher extent compared with those who had quit smoking for more than 6 months before surgery (13/31 vs. 7/144, P = <0.001). No difference was noted between the groups in low-density lipoprotein level (P = 0.880) at 1 year, over time the intervention group tended to deteriorate from treatment goal in low-density lipoprotein level than the control group (20/44 vs. 13/47, P = 0.086).

A person-centered, nurse-led follow-up program did not improve adherence to the medication regimen in patients surgically treated for IC. Adherence was overestimated when self-reported compared to registry-reported. The adherence to the prescribed medication regimen was concerningly low, especially regarding lipid-modifying agents 1 year after surgery. Considering the relatively high relapse rate of smoking among those to quit smoking less than 6 months before surgery, vascular surgery units may want to reconsider the required duration of smoking cessation before revascularization for IC. Further research addressing adherence to secondary preventive measures and increase sustainability of lifestyle changes are needed