The aim, design and setting of the study
The aim of this multi-center, cross-sectional study was to explore the currents status and influencing factors of self-management in patients with NVAF under different anticoagulant therapy among Chinese patients with NVAF in Jiangsu province. The study complied with the Helsinki Declaration and ethical approval for the study was obtained from the local ethical committee and all patients provided an informed consent.
A purposive sampling method was used to recruit hospitalized patients in the different areas of Jiangsu province with NVAF from six hospitals from December 2017 to October 2018. Inclusion criteria were as follows: patients were (1)age≥18 years; (2)AF by electrocardiogram or ambulatory electrocardiogram recorder according to the guideline of the European Society of Cardiology (ESC); (3)had volunteered to participate in this study, and willing to provide informed consent. Exclusion criteria were as follows: (1)AF caused by reversible factors, eg: cardiac surgery, uncontrolled hyperthyroidism; (2)valvular AF; (3)malignant tumors and blood diseases; (4)underwent surgeries within three months.
General information questionnaire
General information questionnaire including demographic and clinical data. Demographic data including age (years), gender, education status, payment, marital status, dwelling status, quality of life (QoL). Clinical data including body mass index (BMI, BMI grouping according to Chinese standards), clinical diagnosis, duration, type of AF, severity of symptom, current drug type, CHA2DS2-VASC score, comorbidities, whether they received radio frequency ablation or re-admission within 6 month and sleep quality. The sleep quality was evaluated by the Visual analog scale (VAS), VAS score < 3 indicated good sleep quality; 4-6 indicated average sleep quality; 7-10 indicated poor sleep quality.
The self-management scales for AF patients
The scales were developed by Lu et al in 2017. Scale 1, 2 and 3 were used to evaluate the self-management in patients without any anticoagulants, taking NOAC or Aspirin group and Warfarin group, respectively. The Cronbach’s α of three scales were 0.732, 0.732 and 0.845 and the cumulative variation rate (%) were 61.90%, 63.09% and 66.11%, respectively, which suggests that the self-management scales have good reliability and validity. Scale 1 included three dimensions, namely: (1)adverse hobbies, (2)daily routine and exercise, (3)monitoring the symptoms of embolism and AF. Scale 2 included 4 dimensions, which added a dimension of monitoring the symptoms of bleeding on the basis of Scale 1. Scale 3 included 5 dimensions, which added a dimension of warfarin-specific management on the basis of Scale 2. The Likert 4-grade scoring system (always, often, sometimes, never) was used for all response items in the scales with a forward score of 0-3 and a reverse score which is the opposite. All the scores of the three scales were converted into percentage system. The higher the score was, the better the self-management of AF patients was. The self-management scales for AF patients were presented in the supplementary materials.
Chinese Version of Atrial Fibrillation Quality of Life Assessment Tool
In 2016, Zhang localized the Heart-Related Quality (HRQoL) questionnaire of Spertus J to (AF-QoL-18 ) for AF patients. The Cronbach’s α of the localized AF-QoL scale (AF-QoL-18 ) was 0.915, which indicated the tool had good reliability. The scale has 17 items, including 3 dimensions of physical, psychological and sex life. The Likert 5-grade scoring system (strongly agree, agree, neither agree nor disagree, disagree and strongly disagree) was used for the response items in the scale, with a total score of 17-85. Before data processing, the score was converted into a percentage system (actual score 85＊100), the higher the score, the higher the quality of life.
The CHA2DS2VASc score
The CHA2DS2-VASc score was calculated for each patient to categorize the risk of stroke by assigning 1 point each for age between 65 and 74 years, a history of hypertension, diabetes mellitus, congestive heart failure, vascular disease (CAD or peripheral artery disease), female sex and 2 points each for a history of stroke/TIA/
thromboembolism and age ≥ 75 years. The total possible score was 9 points and higher scores indicated a higher risk of stroke. According to the 2016 ESC guideline, the high risk of stroke is CHA2DS2VASc ≥ 2 for males and CHA2DS2VASc ≥ 3 for female.
The members of the research team received unified training. Prior to the investigation, the researcher explained the purpose and significance of the study in detail to the patients and made clear that the patients’ privacy will be protected. Patients were asked to sign the informed consent. The questionnaires were issued with unified language guidance to ensure the homogeneity of the investigation. The questionnaires were completed by patients themselves after stating the purpose of the survey. The content of the demographic data were completed by patients themselves and clinical data were obtained from the medical records. For some patients with low education level and impaired vision, the researchers simply and clearly read the questions/item, and the patients made the choice. All questionnaires were collected on the spot and checked whether there were omissions or non-conformance in the questionnaires. If errors were present, the data were completed or modified in time to ensure the accuracy of the information. Due to the difference in understanding the ability and education level of the patients, it took 15-30 minutes to complete the questionnaires.
The SPSS25.0 statistics analysis package was used to conduct the descriptive statistics. Continuous variables were reported as means ± standard deviation (SD) and categorical variables as numbers and percentages. One-way ANOVA was used for mean comparison between multiple groups. The multivariate linear regression analysis was used to analyze the determinants of self-management and P<0.05 was considered statistically significant.