The present research was a quasi-experimental pre and post-intervention controlled study that examined patients with type 2 diabetes under the coverage of Khoy Comprehensive Health Service Centers in 2020 after receiving the necessary licenses from the Ethics Committee and Deputy of Research and Technology at Urmia University of Medical Sciences and also obtaining the necessary consent and licenses from the Deputy of Health Affairs at Khoy University of Medical Sciences. Inclusion criteria of the study were as follows: patients with type 2 diabetes undergoing medication (prescribed by a specialist), with a history of at least 6 months and older, age of 30 to 70 years, having a minimum literacy, no severe physical and mental illness, no participation in similar research or training classes during the last 6 months, and having the consent to participate in the study. Exclusion criteria: Incomplete completion of questionnaires, absence in more than 1 session during 5 training sessions, unwillingness to continue cooperation, and the occurrence of an unfortunate event.
The sample size was equal to 21 per group according to results of the same studies (17), 95% confidence interval, 95% power, and using the sample size formula and comparing the two means (Pukak), and finally, 30 individuals per group were included in the study by taking into account a 30% possible drop. We used the multi-stage sampling method for sampling. First, Khoy city was divided into four geographical directions (north, south, east, and west), and then a comprehensive health service center (four centers in total) was selected as the cluster based on the cluster sampling method. Then, two centers were selected as the intervention group and the other 2 centers as the control group using the simple random sampling method. Then, 15 patients were selected and included in the study by a draw based on the simple random sampling method from each group and among the patients who met the inclusion criteria.
The data collection tool consisted of four sections. The first section consisted of demographic and clinical information, including age, sex, and marital status, and glycosylated hemoglobin (HbA1c) levels based on the result of the last test. The second section consisted of 11 researcher-made questions about awareness of different dimensions of diabetes (including symptoms, complications, treatment, and self-care behaviors). Possible answers to awareness questions were in three options (including yes, no, and neutral). The correct option received a score of 2, the neutral option received a score of 1, and the incorrect option received a score of zero. The minimum and maximum scores for this section of the questionnaire were equal to zero and 22. A high score indicated that patients were well aware of diabetes.
The third section of the researcher-made questionnaire was based on the constructs of the theory of planned behavior about self-care behaviors. The section consisted of 64 questions, of which 16 questions assessed the attitudes of research units towards self-care behaviors about diabetes. There were 16 questions about perceived abstract norms for self-care behaviors, 16 questions about perceived behavioral control for self-care behaviors, and 16 questions about the behavioral intention for self-care behaviors. We used a 5-point Likert scale to score the constructs of the theory of planned behavior, and the scores ranged from 5 (strongly agree) to 1 (strongly disagree). The minimum score was 64 and the maximum was 320. Obtaining a higher score in each construct indicated the participant's good status in terms of that construct.
The initial questions of the researcher-made questionnaire were designed based on the literature review and experts' opinions in fields related to research and instrumentation. We then measured and approved the validity and reliability of the questionnaire, and used face validity (qualitative and quantitative) and content validity (qualitative and quantitative) to determine the validity.
In the qualitative face validity method, we had face-to-face interviews with 10 patients in the target group, and obtained their opinions, and included them in the questionnaire. In the quantitative face validity method, we calculated the impact score of each question. To this end, we used a panel of experts and gave the questionnaires to 10 experts in disciplines related to research and instrumentation and asked them to give each question a score from 1 to 5 in terms of their importance. Questions with impact scores of greater than 1.5 remained in the questionnaire and were otherwise omitted (19).
We used the above-mentioned panel of experts to assess the qualitative and quantitative content validity. In the qualitative method, they were asked to write down their corrective views after a careful read of questions, and we finally obtained their opinions and included them in the questionnaires. In the quantitative method, we calculated the content validity ratio (using the criterion of necessity) and the content validity index (using the criteria of relevance, clarity, and simplicity). Questions with a content validity ratio of more than 0.62 and a content validity index of more than 0.79 were accepted (19).
We utilized the Cronbach's alpha coefficient to assess the reliability of the researcher-made questionnaire. Therefore, we gave the pilot questionnaire to 30 patients in the target group and calculated the Cronbach's alpha coefficient after completing the questionnaires. The Cronbach's alpha coefficient was above 0.7 for all constructs; hence, the reliability was optimal (19).
The fourth section consisted of the Persian version of the Summary of Diabetes Self Care Activities (SDSCA) by Robert et al. (20). The questionnaire was localized in Iran by Hamadzadeh et al. in 2013 (21). It was a self-report questionnaire consisting of 15 questions and examined the diabetics' self-care activities during the last seven days, and included various aspects of self-care, including general and specific diets, exercise, blood sugar testing, insulin injection, or taking anti-diabetic pills, foot care, and smoking. Except for smoking behavior on the scale, which was given a score of zero to 1, the rest of the questions were scored from zero to 7, depending on the number of days when a person performed desired self-care behavior during the past week. Finally, a total adherence score was obtained by summing the scores obtained from each question so that the total score ranged from zero to 99 for the questionnaire. A higher score indicated the good condition of patients in terms of self-care behaviors (20, 21).
The questionnaires were completed by patients of intervention and control groups to determine their educational needs and design an educational intervention, and an educational program was designed based on the constructs of the theory of planned behavior according to the pre-test results. The training program was implemented in five 45-minute training sessions with special educational contents according to patients' needs in the intervention group in groups of 10 to 15 individuals and in accordance with the health protocols of COVID-19. Patients in the control group were not exposed to the educational intervention and received only their routine care.
In the first training session and after introducing and stating the program purpose, we presented generalities about the disease, including the definition of diabetes, types of diabetes, signs, symptoms, and complications of diabetes. The second session focused on ways to prevent and control diabetes, especially through non-pharmacological interventions. The session emphasized physical activity and the importance, consequences, and benefits of regular physical activity so that we could have a positive impact on individuals' attitudes towards this health behavior (physical activity). The third session briefly reviewed the content of previous sessions and emphasized the food groups and the number of calories created by them, especially the importance of a specific diabetes diet, and its effect on blood sugar control, as well as the benefits of changing meals in terms of volume and number. This session sought to increase patients' awareness about different dimensions of diabetes and changing patients' attitudes and behavioral intentions towards diet. In the fourth session, we used special strategies such as verbal persuasion and teaching self-care behaviors in small, simple, and applicable steps to increase the patients' self-efficacy and perceived behavioral control to perform self-care behaviors and thus increase their ability to perform such self-care behaviors without any sense of barriers (16).
The fifth session reviewed the previous content and emphasized the importance of other self-care behaviors and methods that helped control diabetes, such as self-control of blood sugar, and regular use of anti-diabetic drugs, continuous and regular care of feet, avoidance of smoking, and stress management. In the last education session, key and influential people on the patients, who were invited during the previous coordination, were intervened, and their importance and role in supporting patients to perform regular self-care behaviors were emphasized. In all training sessions, the health educator used a combination of teaching methods, both a direct interactive method (Q&A speech, and group discussion) and an indirect method, including the use of educational media such as educational pamphlets and disease-related booklets. The present study with an ethical code (IR.UMSU.REC.1399.231) was approved by the Ethics Committee of the deputy of Research and Technology at Urmia University of Medical Sciences. To observe ethical principles, we obtained informed consent from all participants in the study, and assured them that their information would be confidential after the study, and provided educational packages for the control group.
Statistical Analysis:
The data were analyzed in SPSS 22 using descriptive statistics (mean, standard deviation, percentage, and frequency), and analytical statistics, including Kolmogorov-Smirnov test (to examine the data normality), paired t-test, independent t-test, and ANCOVA. Our results were significant at a statistical level of p<0.05.