Study Design
The study was a multi-center quasi-experimental design involving three hundred and eighty-two (382) persons with type 2 DM purposively recruited from the diabetic clinics of four tertiary health institutions in South East, Nigeria. Ethics approval to carry out the research was obtained from the Institutional Ethics Committee of Nnamdi Azikiwe Teaching Hospital University, University of Nigeria Teaching Hospital, and Federal Medical Center, Umuahia.
Step 1. Selection of Study Area/States used for the study - There are five (5) States that make up the South Eastern Region of Nigeria. Each State houses two tertiary health institutions making a total of ten (10) tertiary health institutions in South Eastern, Nigeria. These States with their tertiary health institutions were listed and a simple random technique with replacement was used to select four (4) States with their tertiary health institutions. The technique involved writing the name of each state on a piece of paper, folded and placed in a bag, a child was asked to pick from the bag one piece of paper at a time. The state picked was written down, and the piece of paper was folded and put back in the bag. This procedure was repeated until four States were selected. The States selected were: Abia, Anambra, Enugu, and Imo States
Step 2: Selection of Study center/ site – Simple random technique was used to select a health institution from each state that making a total of four (4) tertiary health institutions that were used for the study. The institutions are Federal Medical Center, Umuahia, (FMCU), Nnamdi Azikiwe University Teaching Hospital, Nnewi, (NAUTHN), University of Nigeria Teaching Hospital, Ituku-Ozalla, (UNTHI), and Federal Medical Center, Owerri (FMCO).
Step 3: Determination of Experimental (Intervention) and Comparison (Control) groups – Participating tertiary health institutions were assigned to experimental and control groups by randomly assigning each to experimental and comparison (control) health institutions using simple randomization with replacement. This was achieved by writing numbers 1,2,3,4,5,6 on a piece of paper, folded, and placed in a tray. Four girls, (each representing a health institution) were asked to pick a piece of paper from the tray. Odd numbers formed experimental hospitals while even numbers form comparison (control) hospitals. The institutions picked for experimental were UNTH Ituku-Ozalla and FMC Owerri, whereas NAUTH Nnewi and FMC Umuahia were picked as control hospitals. Hence, participants from UNTH Ituku-Ozalla and FMC Owerri formed the experimental (intervention) group while those from NAUTH Nnewi and FMC Umuahia formed the control (comparison) group. The Original sample population for the study was 410. A proportionate sampling technique was used to determine the number of participants recruited from each study site based on the proportion of DM persons from each site to the entire population of DM persons from the 4 hospitals selected for the study. Thus, experimental hospitals which were UNTH Enugu and FMC Owerri had 121 & 86 respectively. DM persons respectively, total = 207. Control hospitals which were NAUTH Nnewi and FMC, Owerri had 103 & 100 DM persons respectively, making a total of 203 DM persons for the control group. However, before the intervention, it was observed that some copies of the questionnaire (9 from the experimental & 10 from the control group) were not properly filled/completed. Also, during the post-test, 9 participants from the control group did not show up, as a result, their pretest scores were removed. In total, we recorded attrition of 28 out of the 410. So the analysis of the questionnaire was based on 198 experimental participants' scores and 184 control participants' scores.
Step 4 Finally, a purposive sampling technique was used in recruiting participants for the study. The researcher met the diabetic persons at the diabetic clinics in the selected health institutions (Experimental and Control health institutions) on different occasions, after introducing the purpose of the study and the steps/procedures involved to them, those that opted for the study and who met the inclusion criteria were recruited. Their names and phone numbers or support persons’ phone contact were collected.
Patient Education- Educational intervention covered areas such as meaning, types, causes, complications of DM, adherence to diet therapy, blood glucose monitoring, physical activity/exercise, foot care, adherence to medication, recognition of symptoms of hypo and hyperglycemia, and actions to take, blood pressure monitoring, regular health checkups on eye care, health care use, 3-monthly laboratory test for glycosylated hemoglobin (HbAic), communication with the physician, lifestyle changes, managing emotional problems as well as stress management.
Method Of Data Collection
Research Assistants
Six research assistants (final year student nurses) trained by the researchers assisted in data collection from the selected health institutions. All the research assistants received training on the areas they were to assist in the study. Each item in the questionnaire was explained to them and the need to maintain objectivity was emphasized. The training of research assistants lasted for two weeks.
The study participants were shared into groups of not more than 25persons/group for easy administration of the questionnaire as well as education of intervention group participants. Each group of study participants was invited to the clinic on a particular day in the week for pre-intervention data collection. Pretest data were collected from study participants (both experimental and control group) who met the inclusion criteria, using both the English and Igbo versions of the questionnaire. Pretest data collection lasted for 6weeks
Educational intervention
Educational intervention material centered on general diabetes management such as involvement in physical activity/exercise, diet adherence, foot care, monitoring of blood sugar, blood pressure monitoring, recognition of signs of hypo and hyperglycemia and actions to take, and eye checkups. Other areas covered include lifestyle changes (avoidance of intake of alcohol/sweetened wine, cigarette smoking, etc.), involvement in healthy social functions (joining the diabetic club, etc.) health care use (even in the absence of symptoms), communication with physician, lifestyle changes, emotional and stress management.
The diabetes self-management education commenced for the experimental group and lasted for 9weeks. An unpublished booklet titled “Managing Your Diabetes” developed by the researchers from a module on diabetes education and other relevant materials was given to the experimental group to go home with. The experimental group was followed up, two weekly meetings were arranged with them to emphasize more on diabetes self-management and also encouraged them to practice self-management. Phone calls were made between meetings to answer the participant's questions. Also, the two weekly meetings helped the researchers to be having contact with the experimental participants to identify the areas they were having a problem with the practice of self-care. The control group participants received normal care during the period of intervention. After six months of commencement of training with follow-up, copies of the questionnaire on quality of life were administered as a posttest to both the experimental and control groups to observe the effect of the education on the quality of life of the intervention (experimental) group.
At the end of the post-test data collection activities, the researchers educated the participants in the control group and gave each of them a copy of the educational material as means of support.
An instrument for data collection: Data was collected using the Rand Short Form 36 (SF-36) Health Survey. SF-36 questionnaire has a total of 36 questions with eight (8) scales that measure 8 dimensions (domains) of an individual’s health. Each scale contains specific questions that assess the quality of life in that domain. The domains are: Physical functioning contains ten (10) questions, Role limitation due to physical health (4 questions), Role limitation due to emotional problem (3 questions), Energy/Fatigue (4 questions), Emotional wellbeing (5 questions), Social functioning (2 questions), Pain (2 questions) and General health (6 questions).
The above domains of the HRQOL were further grouped into two components viz: the physical and the mental components. Scoring of SF – 36 questionnaires was done using RAND Scoring guide. All questions were scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores were compiled as a percentage of the total points possible, using the RAND scoring table. The scores from those questions that addressed each specific area of functional health status were averaged together, for a final score within each of the dimensions measured. The scores were entered into SPSS for statistical analysis.
Method of data analyses:
An Independent t-test was used to compare the baseline QOL scores between the experimental and control groups before the intervention. Analysis of Covariance (ANCOVA) test statistics was used to compare the changes that occurred in HRQOL between the experimental and control groups 6-months post-intervention. Paired samples test was used to examine the changes that occurred between the components of HRQOL. Spearman rank order correlation was used to test the relationship between age and HRQOL domains. T-test was used to test the association between gender and the domains of the HRQOL in all tests, p-value less than 0.05 alpha levels were considered significant.