In this randomized control trial study, participants were recruited from the Karaj Diabetes association (K.D.A.). The data were collected from 22 June to 22 September 2011 for a period of three months. Diabetic patients of both genders, above 30 years of age and ready to sign the consent form, were included in the study. Diabetes was diagnosed by specialist doctor according to the ADA criteria . The inclusion criteria were diagnosed case of type 2 diabetes for more than one year, having mobile phone with ability to handle its SMS feature or having access to one belonging to a relative. The ability to read and write, sufficient vision power, having no problem in hearing and vocalization and no history of psychiatric diseases, HbA1C of above than 7%. They were excluded is if they had a clinical history of major illness such as renal insufficiency with creatinine level > 1.5 mg/dl, hepatic insufficiency and mental illness.
Sample size was determined by considering primary information on HbA1C from study by Zolfaghari, 2009 (SMS group: -1/01 (SD = 0/01) and telephone group: -0/03 (SD = 0/13) , and a confidence level of 95% and a power of 90%, utilizing Pocock formula at least 50 patients in each group. Finally 100 patients were selected on a random sampling scheme where in a list of random numbers was provided before data collection using the software. Admission order of the patients was considered as their ID number and based on the randomization on the ID number the patients were recruited in the study. For allocation to exp. and cont. groups, the researchers use RAS software and randomized by random permuted block design by a size of 2. From all patients in the exp. group (n = 50) and cont. group (n = 50) of the study population only 81 subjects completed the entire study, 43 subjects in exp. group and 38 subjects in cont. group with a response rate of 81% in total. The researchers excluded due to several reasons. In exp. group, two subjects admitted to hospital, one emigrated from Karaj, one bought a new mobile without Persian text message, three patients did not like to continue the study protocol. In control. group, five subjects were withdrawn from the study because they did not revisit the K.D.A. and seven subjects, did not completed questionnaires in post test Therefore, we report data from the 81 subjects who remained to complete the study protocol.
At enrollment, the patient’s demographic characteristics details, body mass index-BMIa (kg/m2),family history of DM,b information disease, disease complications, disease treatment, smoking status,c systolic blood pressure(SBP) and diastolic blood pressure(DBP) were obtained in a suitably designed patient profile form. Additionally, laboratorial tests values like last first blood sugar or glucose (L-FBS), glycosylated hemoglobin (HbA1C), total cholesterol (TC), triglycerides (TG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), micro albumin, BUN, creatinin (Cra) were recorded from the patient’s file, KAP and SE questionnaires were completed as pre - test data. The L-FBS, HbA1C, TC, TG, HDL-C, LDL-C, micro albumin, BUN, Cra, KAP and SE levels were measured again 3 months later (12 weeks) as post test data. Patient’s blood and urine were measured in the Bahar laboratory at the near of K.D.A. Patient’s blood was drown in vains for HbA1 C, FBS, lipids, Cr, BUN measurements. HbA1 was determined by a high-performance liquid chromatography technique.
Prior to starting any education program it is appropriate to gauge the awareness level of the community under study by conducting a KAP study. This will help in implementing a health education program tailored to the needs of the particular community. A suitably designed and validated KAP and self efficacy questionnaire was administered at baseline and at the final follow-up to all the study patients to assess awareness regarding the disease and management. The questionnaires covered four areas: knowledge, attitude, practice and self efficacy. There were a total of 30 questions, consisting of 14 questions related to knowledge about diabetes, 5 questions to assess the attitude of the patient towards the disease, 6 questions regarding practices, which reflect how the patients put their knowledge and attitude into action and 5 questions about self efficacy. One point was awarded for each correct answer and none for an incorrect and unsure answer in part of knowledge and practice. Knowledge and practice (correct answer:1point, incorrect:0point). For part of attitude and self efficacy use Likert-scale in range 5 to 20 score. Attitude (completely agree:4point,agree:3point, disagree:2point, completely disagree:1point), self efficacy (completely sure:4point, fairly sure:3point, less sure:2point, have not sure absolotly:1point). These questionnaires were filled in a face to face interview with the investigator.
Validity and reliability of the measures
The KAP and self efficacy showed good content validity (CVI values > 80% and CVR values > 99%) based on the evaluation of 6 expert in the field of internal medicine, endocrinology and metabolism disorders and education. The reliability of the measures were assessed based on both internal consistency and stability over time by repeating the questionnaire for a 30 randomly selected subjects. The measure showed reasonable internal consistency (α = 75%) and test- retest reliability (ICC = .80 and 95%, CI ≥ .9) [16, 17].
Suitably designed patient profile form
The patient’s demographic characteristics such as: sex (female: 1, male: 2), age (years), marital (single: 1, married: 2, widowed: 3), education level (reading and writing: 1, cycle: 2, diploma: 3, up diploma: 4, bsc and upper: 5), occupation (staff: 1, free: 2, unemployed: 3, house wife: 4, other: 5), child (number), physiological characteristic such as: family history (yes: 1, no: 2), body mass index (18.5-24.9: 1, 25.0-29.9: 2, 30-39.9: 3), smoking status (yes: 1, no: 2), length of time since diagnosis of diabetes or information disease (yes: 1, no: 2), disease complications (yes: 1, no: 2), disease treatment (without: 1, diet: 2, oral drugs: 3, insulin: 4, insulin & drugs: 5, insulin & diet: 6, oral drugs & diet: 7), Systolic blood pressure (mm/Hg) and Diastolic blood pressure (mm/Hg) and laboratory test values like: last fasting blood glucose (mg/dl), glycosylated hemoglobin (%), BMI (kg/m2), micro albumin μg/dl (yes: 1, no: 2), TC (mg/dl), HDL-C (mg/dl), LDL-C (mg/dl), TG (mg/dl) BUN (mg/dl), Cr (mg/dl) were recorded from the patient’s exam report were obtained in a suitably designed patient profile form. Changes in the KAP and SE score, glycemic control and lipid profile were investigated at the end of study. The KAP and SE questionnaires responses were analyzed and used to develop an appropriate educational program.