DOI: 10.7910/dvn/olm1zm
title: Sociodemographic and Health Predictors of Concern about COVID-19 Infection in Cuban Patients with Type 2 Diabetes Mellitus

description: Participants
A total of 203 patients with type 2 diabetes mellitus who attended nine primary care areas in four Cuban provinces belonging to different regions of the country (Pinar del Río, La Habana, Ciego de Ávila and Santiago de Cuba) participated in the study. Participants were selected by non-probabilistic sampling based on the following inclusion criteria:
1. have a diagnosis of type 2 DM according to the World Health Organization criteria,
2. be older than 18 years old,
3. be patients of the health care areas mentioned above, and
4. be willing to participate in the study and to sign the informed consent form.

Patients with mental illness, cognitive deficit (dementia, psychosis or mental disability) or other apparent condition that prevents understanding and completion of the questionnaire were excluded. Although retrospective data on infection rates in diabetic patients suggest that people with type 1 DM are at higher risk for infectious diseases in general, and death rates are similar to those of people with type 2 DM,this study focused on the latterfortwo main reasons. First, patients with type 1 DM are mostly children and young people and the prevalence of this type of diabetes is lower compared to type 2 DM, which leads to a lower number of patients seen in consultation and primary health care. Second, the study was conducted in the context of the COVID-19 pandemic and patients with type 2 DM were the most accessible population to be surveyed by the research team in primary care areas.

The minimum sample size was calculated with the Soper software package for a multiple regression study, according to the desired probability level (α=0.05), the number of predictors in the model (18 predictors), the anticipated effect size (f2=0.15) and the desired statistical power level (1- β=0.80). The software suggested a minimum number of 118 participants; however, the final number was higher than the minimum required.

Instruments
Socio-demographic and health information A questionnaire was developed specifically for this study, where participants were asked to provide information about their sex, age, educational level, type of work, cohabitation, marital status, presence of chronic complications, presence of comorbidities, family or friends infected with COVID-19, and time since diagnosis with DM.

Concern about COVID-19 contagion
We used the COVID-19 contagion concern scale (PRECOVID-19) originally developed for the general population, which assesses worry about becoming infected with COVID-19 and its impact on people’s mood and ability to perform daily activities. In this study we used the version validated for Cuban patients with diabetes, which consists of 5 items. All items have 4 Likert-type response options, ranging from 1=never or
rarely to 4=almost all the time. The PRE-COVID-19 has a unidimensional structure, where the total score is calculated by adding the scores of each of the 5 items. Higher scores indicate greater concern about becoming infected with COVID19. The reliability of the PRE-COVID-19 for this study was very good (ω=0.91).

Blood glucose level
Fasting blood glucose values were obtained from the patients’ clinical histories and from blood tests performed in the last three months in laboratories equipped for this purpose. Based on this, poor glycemic control was determined as fasting blood glucose greaterthan or equal to 7 mmol/L (126 mg/dl) in the last three months and good control as figures below this value. The criterion based on glycosylated hemoglobin (HbA1c) could not be used because it is not a test regularly available in the primary health care system where the survey was applied. Other control criteria using continuous glucose monitoring systems were not possible either, as they are not generally available for patients with DM living in Cuba.

Procedure
The questionnaire was applied by properly trained researchers, who complied with strict COVID-19 prevention health protocols, between the months of January and April
2021. The questionnaire was administered during patients’ visits to primary care centers or in their homes. During this period of time, the fight against COVID-19 in Cuba suffered some setbacks, characterized by an increase in the number of infected people, even higherthan that observed during the first stage of the disease, in 2020. Thus, during those dates, more than 64,414 positive diagnoses and 384 deaths were reported in the country.
Participation was voluntary and without any financial compensation. Participants signed the informed consent form and were informed that they could withdraw from the study at any time. Similarly, the reliability of the data was guaranteed. The study protocol was approved by the Ethics Committee of theUniversidad Privada delNorte in Peru (registration number: 20213002).

Data Analysis
The frequencies and percentages of the categorical variables included in the model were examined. In the case of the outcome variable (concern about COVID-19 contagion), the mean±standard deviation (SD) was calculated for the total sample. These values were then also calculated for each category of each variable. For inferential purposes, bivariate associations were examined with a series of analyses of
variance (ANOVA). The assumption of homoscedasticity was reasonably well met in most cases; however, a possible noncompliance with the assumption of normality of the residuals was observed. Therefore, we repeated the analyses after a power transformation of the outcome variable. Since the results were practically identical with both procedures, only those obtained with the variable in its original form are reported.

Variables that reached statistical significance (p&lt;.05) in the ANOVAs were selected as potential predictors in a linear regression. Crude (simple) regressions were run, which replicated the ANOVAs but also allowed for a more detailed examination of between-group differences. Finally, a fitted (multiple) regression was run with all predictors simultaneously. Statistical significance was judged from the 95% CIs, which provide a set of possible values of the coefficient in the population. A CI that does not include zero is equivalent to a p&lt;.05.