The sample size was planned to be at least 120 in this study, with the set of α = 0.05; β = 0.2; degree of freedom (df) = 120; RMSEA = 0.05 in the null hypothesis; RMSEA = 0.08 in the test of close fit, and RMSEA = 0.01 in the test of non-close fit (37 (link)). The calculation was completed in R 4.2.2.
A descriptive cross-sectional questionnaire survey was conducted in the present study. Participants were recruited from Zhongmu, Henan province, China, and they were invited to fill out a questionnaire including demographics and DSMS by convenience sampling from November 2nd, 2021 to November 12nd, 2021. The inclusion criteria were: (1) Registered clinically diagnosed diabetic patients aged from 45 to 65 years old; (2) Fasting blood glucose level is not lower than 7.0 mmol/L or HbA1c is not lower than 6.5%; (3) Can independently finish questionnaires; (4) Can sign the informed consent form and cooperate to complete all the research contents. The exclusion criteria were: (1) Patients with serious diseases (such as malignant tumors), immunodeficiency or immunosuppressants, or those with severe neurological or mental disorders; (2) Patients who are deaf-mute, unable to move, etc. Investigators who are familiar with the local dialect were recruited and trained. Unified instructions were set for each item in the questionnaire for the investigators to ask questions, and they would fill out the questionnaire according to the answers of the participants. After the investigators and proofreaders sign at the end of each questionnaire, it is deemed that the investigation of this sample is completed. Epidata software was used for data entry and double check to ensure the accuracy of the data. In this study, 484 participants completed the questionnaires, and 469 out of them met the eligibility criteria of the study, which were employed for subsequent analysis, with an effective recovery rate of 97%. The study protocol was approved by the Ethics Committee of the Institute of Pathogen Biology, Chinese Academy of Medical Sciences (Beijing, China) (IPB-2021-09).
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