In this semi-experimental controlled study, 105 patients with type 2 diabetes visiting Diabetes Research Center in the city of Birjand (southeast of Iran) were recruited. According to the study of Jalilian et al. (2010) and taking into account the confidence level of 95% and power of 80%, the sample size was calculated as 18. However, due to sample attrition and to improve the accuracy of the study, 35 samples were entered into the study (
23).
The inclusion criteria were 30 - 55 years of age, at least one year elapsed since the diagnosis of type 2 diabetes, no history of type 1 or gestational diabetes, having the ability to read and write, lack of speech, mental and hearing problems, no history of participation in training courses, and not having diseases such as renal failure, stroke, malignant tumors, or psychiatric disorders.
Participants were selected from the diabetes research center using the connivance sampling method, then they were randomly allocated into three groups of 35 participants, namely teach-back, video tape training, and control.
A daily drawing method was applied to select the groups. This was conducted according to the following procedure: the names of groups were written on a piece of paper on a daily basis. The first name was randomly picked by the investigator. Following this, the patients were alternately placed in the control and intervention groups. This procedure would continue until the number of participants in each group reached to 35. The participants received sufficient information about the study objectives and the procedures, and then informed consent forms were filled out by them. The training sessions were held in the educational classes of the Diabetes Research Center.
To collect data the following three questionnaires were employed: (1) Orem’s nursing assessment form developed by Memarian with targeted questions in the six areas of demographic data, clinical data, history of previous diseases, public self-care requisites, common health patterns, health deviation, and self-care requisites (
15,
21). (2) The researcher-made questionnaire of self-care behaviors assessment developed based on the summary of Diabetes Self-Care Activity (SDSCA) measure (
22) in which the two areas of diet and medication were removed. Indeed, to cover the research objectives, two questions were added to the area of physical activity and four additional ones were added to the areas of foot care. The current tool is expected to assess the adherence behaviors of subjects in three areas of physical activity, glycemic control, and foot care during the recent seven days. The questionnaire included four items related to physical activity, two questions designed to assess glycemic control, and six other questions addressed the area of foot care. On this scale, a score of zero to seven was dedicated to each behavior, and the total score of self-care was the sum of the item scores and could vary between 0 and 84. The internal consistency of the study was established with the Cronbach's alpha of 0.71. Content and face validity of the scale was confirmed by five faculty members of Birjand University of Medical Sciences (departments of internal surgery, management, and public health). (3) A self-Efficacy questionnaire was developed based on the diabetes management self-efficacy scale (DMSES) (
23,
24). Considering the research objectives, questions related to the areas of physical activity, glycemic control, and foot care were introduced. This questionnaire included eight items designed to assess the ability of patients in the areas of foot care, physical activity, and glycemic control. The items were rated on a 5-point Likert-type scale (5 = I definitely can do, 4 = I can probably do, 3 = I'm not sure I can do, 2 = I can’t probably do, 1 = I can’t definitely do). The total score of self-efficacy can vary between 8 and 40. The internal consistency was calculated using Cronbach’s alpha as 0.82. Face and content validity were confirmed by five faculty members of Birjand University of Medical Sciences (departments of internal-surgery, management, and public health).
The diabetes self-care assessment questionnaire was used to determine the mean score of self-care in all the three groups, such that if the mean score was less than 70%, a need for training was raised and the patient was enrolled in the study. Following this, the intervention group was examined by the existing Orem’s form. Then, the training program was developed based on the training needs of the intervention group.
The number of training sessions in the teach back group was determined based on the extent of self-care disability in the areas of physical activity, foot care, and glycemic control. Accordingly, 2 - 3 sessions were held for each patient individually using the face to face approach of learning. A glucometer was used to determine the approximate concentration of glucose in the blood. Each session lasted approximately 30-45 minutes.
By the end of each session, the individual patient was asked to explain what he/she had learned. For example, they were asked how to shorten their nails? or how to warm up their feet in winter?
If they could provide the instructor with a satisfying answer, the session was terminated, otherwise that discussion would continue with more clarity until sufficient understanding was achieved.
Afterwards, the participants of the video tape group were divided into four groups of 8 and 9 members. Three half-hour video films prepared by the Endocrinology and Metabolism Institute of Tehran University of Medical Sciences were presented to the subjects. These videos were elicited based on self-care deficits regarding physical activity, foot care, and glycemic control.
The control group received no intervention. The self-care and self-efficacy questionnaires were recompleted by interviews after 7 days and 1 and 3 months, respectively.
Data were analyzed using SPSS version 16. Chi-square, Fisher’s exact test, and Student’s t-test were run to analyze the demographic data. To assess variation in the mean scores of self-care and self-efficacy, one way ANOVA and Kruskal-Wallis tests were used. In addition, to compare the mean total score of self-efficacy and self-care in the area of foot care, intra-group analysis of variance was used during four stages, and due to abnormality of self-care variables in the areas of physical activity and glycemic control, the Friedman and Wilcoxon tests. A P-value of less than 0.05 was considered significant.
The study protocol was approved by the Ethics Committee of Birjand University of Medical Sciences, Birjand, Iran (IR.BUMS.REC.1394.405). Informed consent was obtained from the patients. The participants were ensured that their names and other information would remain confidential. Participation in the study was based on willingness and the participants were allowed to withdraw from the study at any time.