Study design, area, and period
Institution-based cross-sectional study design was employed from April 02, 2019 to June 02, 2019 at Addis Zemen District Hospital, northwest Ethiopia.
Source and study population:
All Type 2 diabetic patients of Addis Zemen Hospital were the source population and all type 2 diabetic patients who came to diabetic clinic during the 3 months of data collection period were the study population.
Sample size determination and sampling technique:
The sample size was calculated by using a single population proportion formula with assumptions; p=50% (as there was no previous study in Ethiopia), 95% level of confidence and 5% margin of error. Then sample size became 384. After adding 5% oversampling, the minimum calculated sample was 404. Computer generated simple random sampling technique was used to select the study participants.
Inclusion and exclusion criteria
All type 2 diabetic patients who were on medication for more than one year and ≥18 years old were included. All type 2 diabetes mellitus patients who were seriously ill and health professionals were excluded.
Variables of the study
Dependent variable: awareness
Independent variables: Age, sex, residence, marital status, occupation, educational status, income, duration since diagnosis as diabetic, family history DM,
DM complications: presence of one or more of complications on DM patients such as retinopathy, diabetic foot, renal complications, stroke, heart complications, teeth decay, neuropathy, hypertension, and sexual dysfunction (20).
Rural residence: settling in country side outside of big cities or towns in Ethiopia are referred as rural residents (21).
Family history of DM: having at least one‐first‐degree relative with diabetes (22).
Data collection instrument and procedure
Pretested structured interviewer-administered questionnaire, which is adapted from different literatures, was used to collect the data (15,23-26). The questioner contains 28 diabetes complications related awareness items. The possible correct answers for assessing awareness of diabetes complications were 28. The awareness of the patient was calculated by summating the correct answers and calculating the mean value as 15 with minimum and maximum correct answers of 5 and 25 respectively. The participant who mentioned less than mean (15) correct answers grouped as have no awareness. The participant who mentioned ≥15 correct answers grouped as having awareness. The questionnaire was prepared in English first and translated to local language and then, re translated back to English by another person to check its consistency and wording.
Data quality management/control:
Training was given for data collectors and supervisors about the aim of the study, data collection procedure and ethical issues. Validity was checked by doing pretest on 60 type 2 DM patients at University of Gondar Hospital (out of the study area). Modification of the tool was made based on the pre-test result. The Cronbach’s alpha scale for awareness questions was done for all questions and it was greater than 0.7, which is acceptable. Close supervision was made during data collection. Data clean up and crosschecking was also done before analysis.
Data analysis procedure
The data were checked for completeness and entered to Epi Info version 7 and were exported to SPSS Version 20 for analysis. Descriptive statistics such as frequencies and percentage were used. A binary logistic regression was used to identify predictors of awareness on DM complications. On bivariable analysis, variables with a p-value < 0.2 were entered to multivariable logistic regression model. P≤0.05 were used to declare statistically significant variables in the final model.