Study design and setting
Institutional-based cross-sectional study in the form of an interview was conducted in randomly selected primary hospitals of Northwest Ethiopia, located Northwest of Addis Ababa. The study period was fromMarch1, 2019 to May30, 2019. Essential information was obtained through administration of structured questionnaire-based interviews .The study area had one comprehensive specialized referral and teaching hospital, one private general hospital in Gondar town, ten primary hospitals and a number of health centers. The study participants were recruited from the selected primary hospitals, such as in Addis Zemen, Debark, Wogera, Kolladiba, Chilga, and Metema.
Source population, Sample size determination and Sampling procedure
The source population was all diabetic patients who had been treated with insulin in the study area. The study population included those diabetic patients who were using insulin as their primary therapy or as an additional therapy and visited those hospitals during the study period. Patients’ or patient care givers who were 18 years of age and above were included in the study. The patient should be on insulin treatment for at least one month and refilling insulin prescription at the hospital. Patients who did not volunteer to participate in the study or those who were seriously ill, unable to hear or speak, physically disabled, having dementia or cognitive impairment, and difficulty of getting consent were excluded from the study. A convenient sampling technique was used to collect data.
Data collection instruments, procedure and management
The data collection format was initially prepared in English. It was then translated to the local language (Amharic) and back translated to English to ensure proper meaning. Trained pharmacy professionals, under investigators daily supervision, collected the data. The questionnaire focused onsocio-demographic and related information, experiences, practices and knowledge of insulin storage and handling techniques, and observational checklist of patients’ skill related to self-insulin administration. Both the practice and the knowledge questions contain 14 items. Practices were measured by Likert scale type (Never=1; Sometimes=2; Often/Usually =3; Always=4) and graded as poor, fair and good if they scored<50% (<28), 51-75% (29-42) and >75% (>42)out of 56 points, respectively. The knowledge of respondents’ was measured with dichotomous outcomes as “right” who answered the question correctly and “wrong” who answered the question incorrectly. A score of >75% (>10.5),(51-75% (8-10.5),and<50% (<7) out of 14 points were said to be adequate, moderately adequate, and inadequate, respectively[20]. The respondents’ skills were measured through five observational (demonstration) techniques related to insulin self-administration procedures. The checklist marked as correct =2, incorrect =1 and skipped =0 based on American diabetic association of insulin administration[21, 22]. If a patient or a caregiver correctly performed all the critical steps, the observation (demonstration) was considered as correct; if any of the critical steps was missed or performed incorrectly, the demonstration was considered as incorrect; and it is considered as skipped if any of the steps was jumped.
Data entry, analysis, and interpretation
The data was entered and analyzed using statistical package for social sciences (SPSS)for windows, version 22.0.[23]. Frequencies, percentages, median and a chi-square test were used to estimate the differences in magnitudes of categorical variables while non-parametric Kruskal-Wallis H test and Mann-Whitney U test were done for analysis of the mean of continuous variables. Pairwise multiple comparisons was done for those groups who had significant knowledge and practice median differences on the Kruskal-Wallis H test. The knowledge and practice data were transformed into categorical values. The knowledge levels classified as inadequate, moderately adequate and adequate knowledge; and practices levels also expressed as poor, fair, and good practices. P-value < 0.05 and 95% confidence interval (CI) were used as cut-off points for determining statistical significance of associations among different variables. The Pearson’s correlation coefficient test was done between the patients’ knowledge and their practice levels in their insulin handling techniques and injection practices.
Data quality control
Before any data collection performed, a pretest was done on 15 patients from one of the randomly selected primary hospital.. These patients were not included in final data analysis. Important amendments were made and formatted as needed. The data accuracy and completeness were consistently checked by using double entry and any mistakes and omissions were corrected.
Informed consent and Confidentiality
Before any of the activities, written informed consent were sought from the participants. The voluntariness of the participation and the aims of the study were explained clearly and shortly. The participants’ were given the right to interrupt at any time if they do not want to continue. The respondents were interviewed and were observed while doing a demonstration privately and independently. All information was kept confidentially by giving serial numbers.