Study area and period:
The study was conducted at 3 selected hospitals called Hawassa university comprehensive specialized hospital, Wolaita Sodo University Teaching Referral Hospital and Nigist ellen general hospital. Hawassa University Comprehensive Specialized Hospital is a teaching Hospital located 275 km south of Addis Ababa, in Hawassa town Sidama region. Nigist Ellen Mohammed Memorial hospital is the General hospital found in Hadiya Zone, which is 230 kilometer from Addis Ababa. Wolaita Sodo University Teaching Referral Hospital is also found in Sodo town which is 328km from Addis Ababa
Study period: The study was conducted from October 24, 2021- February, 30, 2021
Institution based cross sectional study design had been conducted at selected hospitals of southern Ethiopia.
Source population: All diabetic patients who attended selected hospitals of southern Ethiopia during study period.
Study population: All sampled DM patients who attended outpatient department at selected hospitals of southern Ethiopia during the study period
Inclusion and exclusion criteria
All diabetic patients who attended outpatient department at selected hospitals in southern Ethiopia who can give informed consent will be included. Whereas, those who are not volunteer have been excluded
Sample size calculation is based on the single population proportion formula.
N= [(Zα /2)2 P (1 – P)]/d2 is used.
N= is sample size,
Zα/2 is Z value which is 1.96 at 95% confidence interval,
P is proportion of diabetic patients and is taken 0.5 and d is marginal error which is 0.05.
At 95% confidence interval and by taking p value of 0.5 just to maximize the sample size; in order to accommodate the maximum variety of patients coming to the diabetic clinics, the sample size will be 384. Adding 10% non-respondent rate, the final sample size will be 422.
The study area was selected randomly using lottery method from those hospitals found in southern region of Ethiopia. Proportionate sample allocation was done to allocate samples for each hospital of Adare general hospital, Nigist Ellen general hospital and Wolayta sodo general hospital. So, every patient having appointment during study period was selected since patients visiting the health institutions are random in nature till the maximum number of sample size will be achieved. So, exit interview was conducted at each hospital.
Socio demographic variables: - Age, Sex, educational status, marital status, income and job status.
Behavioral Variables are: - Alcohol drinking, cigarette smoking, Khat chewing, Physical activity practice, practices to prescribed diet regimen.
Disease and medication related Variables are: - Duration of Diabetes, Type of treatment, co-morbid illness, Fasting blood glucose level, DM control, Medication adherence
Data collection Instrument
In order to collect data from the patient, Data abstraction sheets, structured questionnaire and observation checklist was used. Data abstraction sheets were developed by investigator by reviewing different literature to collect relevant information from patient charts and laboratory results. Structured questionnaire for face to face interview was used to obtain patient Adherence level will be classified by taking the sum of 8 question responses and grouped as high, medium or low, if the total score will be ≥3 1 to 2 and 0, greater respectively using Morisky medication scale . The questionnaires have 6 parts, including socio-demographic information, Patient’s Physical activity questions, the Morisky medication adherence Scale with 8 items (MMAS-8) and laboratory and medication related variables. The data have been collected by 11 BSc Nurses and 3 M.Sc. health professionals had supervised data collection process. At the end the outcome will be measured which may be good or poor treatment outcome
Data processing and analysis
After checking collected data visually for completeness, the responses was cleaned, edited, coded and entered into the computer using Epi-data version 3.1. The data will be then exported to SPSS version 20.0. The data will be checked for missed value before analysis. The descriptive analysis including frequency will be used to assess frequency of variables with independent variables. Binary logistic regression will be carried out to assess the association of treatment outcome of DM with independent variables to determine predictors of treatment outcome having odds ratios with 95% confidence interval. Finally forward stepwise logistic regression model with all independent variables having p value <0.25 will be fitted and adjusted odds ratio will be calculated to identify independent predictors of treatment outcome of DM.
To assure quality of the data, properly designed data collection tool was prepared, pretested in hospital which would not be selected to check for understandability and applicability of the instrument and 3 day training will be given to data collectors and supervisor. Besides, on each data collection day, the collected data was reviewed and checked for its completeness by supervisor and principal investigator. Then data was checked and entered into Epi-data version 3.1 for double data entry verification.
In order to follow the ethical and legal standards of scientific investigation, the study was conducted after approval of the proposal by Ethical Review Committee of Hawassa University. Permission for conduct of study was obtained from authorities at selected hospitals. Written informed consent was obtained from each study participant by assuring privacy and confidentiality throughout the data collection period in the Hospital. Individuals who were unwilling to participate from the beginning or at any part of the interview were allowed to withdraw. There was no risk or hazardous procedures putting the participants at harm.