PURPOSE: To compare whether health-related quality of life (HRQoL) is altered in patients undergoing a treatment strategy guided by changes in dietary vitamin K. METHODS: This study is a randomized clinical trial carried out with chronic oral anticoagulation outpatients randomized into a control group (conventional dose adjustment of oral anticoagulants) (n = 66) and an intervention group (strategy based on changes in dietary vitamin K intake) (n = 66). HRQoL was measured using the Duke Anticoagulation Satisfaction Scale (DASS) at baseline and 90 days of follow-up. RESULTS: Patients with worse HRQoL were younger (p = 0.005) and were using a higher dose of baseline oral anticoagulants (p = 0.008), while those with better HRQoL scores had a higher level of education (p = 0.01). Both groups had significant improvements in HRQoL from baseline to 90 days in the global DASS score (p < 0.001), as well as in the negative and positive psychological impact (p < 0.001) domains. We did not observe differences in the variations of HRQoL scores in any of the DASS domains (p values > 0.05) between groups of interventions. Patients who achieved oral anticoagulation stability (n = 23) had significantly better HRQoL scores than patients who did not achieve stability (p = 0.003). CONCLUSION: Patients receiving the treatment strategy based on changes in dietary vitamin K intake did not have better HRQoL scores; however, both treatment approaches to manage oral anticoagulation improved HRQoL. Patients with greater oral anticoagulation stability had better HRQoL scores.
RCT Entities:
PURPOSE: To compare whether health-related quality of life (HRQoL) is altered in patients undergoing a treatment strategy guided by changes in dietary vitamin K. METHODS: This study is a randomized clinical trial carried out with chronic oral anticoagulation outpatients randomized into a control group (conventional dose adjustment of oral anticoagulants) (n = 66) and an intervention group (strategy based on changes in dietary vitamin K intake) (n = 66). HRQoL was measured using the Duke Anticoagulation Satisfaction Scale (DASS) at baseline and 90 days of follow-up. RESULTS:Patients with worse HRQoL were younger (p = 0.005) and were using a higher dose of baseline oral anticoagulants (p = 0.008), while those with better HRQoL scores had a higher level of education (p = 0.01). Both groups had significant improvements in HRQoL from baseline to 90 days in the global DASS score (p < 0.001), as well as in the negative and positive psychological impact (p < 0.001) domains. We did not observe differences in the variations of HRQoL scores in any of the DASS domains (p values > 0.05) between groups of interventions. Patients who achieved oral anticoagulation stability (n = 23) had significantly better HRQoL scores than patients who did not achieve stability (p = 0.003). CONCLUSION:Patients receiving the treatment strategy based on changes in dietary vitamin K intake did not have better HRQoL scores; however, both treatment approaches to manage oral anticoagulation improved HRQoL. Patients with greater oral anticoagulation stability had better HRQoL scores.