Participants
This study is quasi experimental research. Participants were recruited from the Iranian Diabetes Association. We studied this intervention during a three month period starting in May 2008. Diabetes was diagnosed according to the American Diabetes Association (ADA) criteria. The age range was 18–65 years. Patients had to have telephone access in their homes and have their own personal mobile phone, or have access to one belonging to a relative. Although selection criteria required that participants should be diabetic patients that only use Oral anti-diabetic medications, should be able to read and write, have power vision sufficient, no problem in hearing and vocalization and no history of psychiatric diseases. Patients were excluded if they had a clinical history of an important illness such as renal insufficiency with a creatinine level >1.5 mg/dl, hepatic insufficiency, were mentally ill or had less than 7% of HbA1c.
Seventy nine patients met the above criteria and agreed to participate. They were randomized by random permuted block design using a random number table and assigned to one of two groups: SMS group (N = 39) or Telephone group (N = 40). Only 77 subjects completed the entire study, 38 SMS and 39 Telephone. Two subjects were lost before completing the post-test in the Telephone group: one decided to opt out of the programme before completing the post-test and one expired during intervention. One subject was lost before completing the post-test in the SMS group because the change of therapeutic regimen from oral anti-diabetic agents to insulin.
Ethics committee approval was required. For ethical considerations, the research protocol was approved by the Medical Research Ethics Committee of the Tehran University of Medical Sciences. Written consent was obtained from those patients who agreed to participate in the study. Anonymity and confidentiality were guaranteed to participants.
Intervention
The goal of the intervention was to maintain blood glucose levels within a normal range. Participants attended in three days diabetes self-care education in Iranian Diabetes Association. Before the intervention, each patient was instructed, for 10 minutes by researcher, about how to use their own cell phones and to check their ability to read Short Messages and match the time for telephone follow-up. The researcher provided the intervention for 12 weeks. Patients in the SMS group received about 4 messages weekly consisted of diet, exercise, diabetic medication taking and frequent self-monitoring blood glucose levels. Participants in SMS group could receive our messages at any place where access was possible by cellular phone. The researcher sent optimal recommendations back to each patient, 4 times by short message service of cellular phone weekly. For example, recommendations included: ‘Do you know, the best bread for you is pebble bread’; ‘Please eat vegetables and salad in every meal’; ‘Please for prevention of high glycemic fluctuations’, eat your meals in six times instead of three times’; ‘Please consume your drugs on prescribed times’ ; ‘Do you know, eating in regular times, helps you to control your diabetes better’; ‘Lack of exercise may be the cause of the aggravated glucose level’; ‘Try to exercise 3 times daily and at least 15 minutes every time’; ‘Do at least 30 minutes of physical exercise or walking’; ‘Please check the amount that you eat’; ‘Take your recommended diabetic medication’; ‘If you consume Glybenclamide, please eat it, 30 minutes before your meal’ and so on. The 12 weeks of intervention consisted of continuous education and reinforcement of diet, exercise, medication taking, as well as frequent self-monitoring of blood glucose levels.
The intervention for Telephone group was provided via telephone for 12 weeks. The 12 weeks of intervention consisted of counseling on the nature of the disease, risk factors, importance of maintaining blood glucose levels within a near-normal range, continuous education and reinforcement of diet, exercise, medications taking, hypoglycemia management, illness management how to record daily blood glucose and frequent self-monitoring of blood glucose levels. The researcher contacted the telephone group at least twice a week for the first month and then weekly for the second and third month. The total frequency of telephone counseling averaged 16 times per subject. The duration of each counseling session was an average of 20 minutes. The researcher was asking questions such as: “did you take your recommended diabetic medication?” “When did you consume your prescribed tablet?” Do you know how you’re consuming medications, act in your body? “How many times did you do physical exercise or walking during last days?” “When is the best time to do exercise?” “Did you feel better after doing exercise?” Do you know that doing exercise is as important as diabetic medication?“ How many days did you follow your recommended diet over the past days?” Did you eat salad and vegetable before every meal?” Before initiation of recommendation, researcher asked every patient about problems they were facing during last days and patients could ask their questions and could solve their problems. Sometimes they feel stress, so the researcher educate some ways of decreasing stress such as: deep breathing, distraction methods, taking a bath, go to the country, concentrate to good points of their life, be more with their family members or closed or lovely friends, try to laugh more and so on.
Procedure
Before the intervention, demographic characteristics and HbA1c value were collected as pre-test data at the Iranian Diabetes Society. The intervention was provided to the telephone group with counseling appointments scheduled when convenient to the subject. The HbA1c was measured again three months later. Patients’ blood was drawn in veins for HbA1c measurement. HbA1c was measured in the metabolism and endocrinology laboratory of the Tehran University-affiliated medical center. HbA1c was determined by a high-performance liquid chromatography technique. HbA1c level was measured after 12 weeks as posttest data.
Data analysis
The data were analyzed using the SPSS (Version 11.5) program. Chi square test, Paired t-test, independent t-test and Fisher’s exact test were used to test for the homogeneity of demographic and clinical characteristics between the SMS and Telephone groups. The paired t test was used for comparison of differences between pretest and posttest values in the group. The unpaired t test was used for comparing the differences between the SMS and Telephone groups.