Reliability And Validity Of The Chinese Version Of The Clarke Questionnaire And Its Application With Type 2 Diabetes Mellitus

Objectives1.To introduce and translate the impaired awareness of hypoglycemia(IAH)assessment scale and to test its reliability.2.To analyze the current situation of IAH in Chinese patients with type 2 diabetes mellitus(T2DM)and the influencing factors.3.Understand the real experience of IAH in patients with type 2 diabetes.4.To investigate the relationship between IAH,Illness perception(IP),Fear of hypoglycemia(FOH)and mild cognitive impaired(MCI)in patients with T2DM.Methods1.Obtain authorization to translate and use the Clarke Scale from the original author professor.After forward translation,back translation,cross-cultural debugging and preexperiment,the Brislin translation model was adopted to form the Chinese version of Clarke Scale.A total of 334 inpatients with T2DM were selected by convenience sampling method for questionnaire reliability and validity investigation.Item analysis was used to test the differentiation and homogeneity of questionnaire items,and Cronbach’s α coefficient,retest reliability and broken half reliability were used to test reliability.Item content validity index and total questionnaire content validity index were used to test the content validity of the questionnaire,and exploratory factor analysis and confirmatory factor analysis were used to test the structural validity of the questionnaire.2.The study on the current status of IAH and the factors affecting it in T2DM patients used quantitative research.In this study,251 patients with T2DM hospitalized in the endocrine departments of two tertiary hospitals in Yangzhou City were surveyed with the General Information Questionnaire,the Chinese version of the Impaired Hypoglycemia Awareness Assessment Scale,the Simple Illness Perception Questionnaire,Chinese version of Hypoglycemia Fear survey Ⅱ-Worry Scale,and the Montreal Cognitive Assessment to analyze the current situation of IAH and understand the influencing factors of the patients.3.Purpose sampling method was used to select 13 patients with T2DM and IAH who were hospitalized in the endocrinology department of two third-class A hospitals in Yangzhou City as the research objects.Semi-structured in-depth interviews were conducted on them.Colaizzi 7-step analysis method was used to analyze the data,summarize and extract the themes.4.In this study,Excel was applied to create a database,which was entered and checked by two people.SPSS 27.0 and AMOS 27.0 software were applied for data analysis.Statistical methods included:descriptive analysis,t-test,chi-square test,Fisher’s exact probability method,binary logistic regression,Pearson correlation analysis,Spearman rank correlation analysis,and mediation effect test.Results1.Translation and reliability test of the impaired awareness of hypoglycemia assessment questionnaire for type 2 diabetic patientsAfter translation and cross-cultural debugging,the content of the questionnaire was consistent with the Chinese cultural background and expression habits,and the language was simple and easy to understand.The validated Chinese version of IAH assessment scale had 8 items.The Cronbach’s a coefficient of the total questionnaire was 0.802,the half reliability was 0.792,and the retest reliability was 0.887.The content validity evaluation of the Chinese version of IAH assessment scale by eight experts showed that the content validity index(ICVI)of each item of the questionnaire ranged from 0.833 to 1.000,and the content validity index(S-CVI/Ave)of the total questionnaire was 0.875.The exploratory factor analysis extracted two common factors,which cumulatively explained 52.669%of the total variance and the loading value of each item on the corresponding common factor was above 0.40.The results of the validated factor analysis showed χ2/df=1.768,IFI=0.959,TLI=0.926,CFI=0.973,GF 1=0.973,AGFI=0.938 and RMSEA=0.060,all of which met the fitness criteria.2.The study of the current status of IAH in type 2 diabetes and the influencing factorsThe study was conducted on 251 patients with T2DM included,of whom 26 were IAH patients,indicating a prevalence of IAH of 10.4%.The results of univariate analysis showed that IAH in T2DM patients was associated with age,occupation,education,duration of diabetes,treatment regimen,frequency of hypoglycemia in the last 6 months,severe hypoglycemia,nocturnal hypoglycemia,knowledge of hypoglycemia,fear of hypoglycemia score,illness perception score,and MCI(P<0.05).Binary logistic regression results showed that severe hypoglycemia(P<0.01),nocturnal hypoglycemia(P<0.05),FOH(P<0.001),IP(P<0.05),and MCI(P<0.001)were influential factors for IAIH in patients with T2DM.3.Real experience of IAH in patients with type 2 diabetesBy interviewing 13 patients and organizing the interview data,a total of 3 themes of real experiences of IAH in T2DM patients were extracted,namely,decreased ability to perceive hypoglycemic symptoms,fear of adverse consequences caused by IAH,and strong need for knowledge about coping with IAH disease.Fear of adverse consequences caused by IAH included three sub-themes of developing negative emotions,increased self-perceived burden,and memory loss.4.Study on the relationship between IAH,FOH and MCI in patients with type 2 diabetesAmong 251 type 2 diabetic patients surveyed,the mean IAH score was(1.65±1.54),the mean IP score was(37.74±5.89),the mean FOH score was(16.35±5.25),and the mean MCI score was(26.90±3.10).There was a significant correlation between ILAH and FOH,IP and MCI.The mediating effect model between IAH and IP,FOH and MCI constructed in this paper based on the Common Sense Model of self-regulation fitted well with the following fit indices:GFI=0.933,NFI=0.943,CFI=0.942,IFI=0.964,AGFI=0.938 and RMSEA=0.074.The relationship between IAH,IP,FOH and MCI in type 2 diabetic patients.The relationship between FOH and MCI contained a total of 1 direct pathway and 3 indirect pathways,namely:(1)IAH→MCI;(2)IAH→IP→MCI;(3)IAH→FOH→MCI;and(4)IAH→IP→FOH→MCI.Conclusion1.The Chinese version of the Impaired Awareness of Hypoglycemia Assessment Scale has good reliability and validity in the Chinese cultural context and can be used as a usable assessment tool for IAH in patients with T2DM.2 Severe hypoglycemia,nocturnal hypoglycemia,IP,FOH and MCI were the influencing factors of IAH in T2DM patients.IAH has a reduced ability to perceive hypoglycemic symptoms,a fear of adverse consequences caused by IAH,and a strong need for IAH coping knowledge.At the same time,recurrent hypoglycemia makes the patient’s memory significantly decreased.Therefore,health care professionals should screen patients with IAH as early as possible and take appropriate interventions to delay the progression of IAH in a timely manner.3.The pathways of IAH,IP and FOH on MCI in type 2 diabetic patients based on the Common Sense Model of self-regulation include one direct pathway and three indirect pathways:IAH can directly affect MCI;and IAH can indirectly affect MCI through the mediating role of IP or FOH,and finally IAH can indirectly affect MCI through the chain mediation of IP and FOH.The results present the potential mechanisms of each variable affecting MCI in patients with type 2 diabetes and provide a theoretical basis for the construction of subsequent intervention programs.