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IRCT20221028056323N1 IRCT 2022-12-23 Mashhad University of Medical Sciences The Effect of Teaching Self-Care Program in Patients with Type 2 Comparison of The Effect of Self-Care Program Training in Two Ways Face-to-Face and Smartphone Application On Adherence to Treatment Regimen and Glycosylated Hemoglobin of Patients with Type 2 Diabetes 2022-12-06 anticipated 60 Complete https://irct.ir/trial/66549 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The randomization unit is individual and the tool being used is SPSS. In this way, all eligible patients will be randomly selected and will be divided into two groups; A and B, using SPSS 26 software. To perform randomization by SPSS, the “Data” option is selected from the toolbar. Next, in the new window, the “select cases” is selected. Then, in the “Select” box, first a click on “Random sample of cases” and then on “select” option will be done. After the “Exactly” option has been selected in the new window, the number of patients in each group and the total number of samples are respectively entered in the empty boxes ( in this study, 30 and 60 respectively). After that, a click on the “Continue” and “OK” options will be done and finally, the generated random variables are randomly divided into two equal groups with codes 1 and 0 on the “Data view” page which conventionally, code 1 is assigned to the intervention group and code 0 to the control group. Patients will be randomly placed in either the intervention or control groups by someone other than the main researcher and statistical analyst. N/A Type 2 diabetes. Intervention 1: Intervention group 1: In this group, self-care training is done face-to-face during three one-hour sessions at intervals of one week. The patients are placed in groups of 6 to 8 people and the researcher will provide necessary information related to self-care training (nutrition management, drug management, activity management, and blood sugar check). Intervention 2: Intervention group 2: In this group, self-care training conducted for three months through a smartphone application. This application includes specific training in the field of self-care for type 2 diabetes patients (nutrition and activity management, medication management, and blood sugar check). This app is a type of educational app that has self-care educational facilities (text, audio, and video) and important titles are presented in a highlighted form. It is also possible to communicate with the researcher in the form of text, and the patient will receive his answer after sending the question, and if he goes online, he will be able to learn new materials. After designing and building the above application, in a 15-20 minute session, the application will be installed on the phone and necessary explanations will be given to the patients regarding how to use it. Two weeks after the application is installed, the patients will be contacted and the ability and efficiency of the application will be evaluated. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Mahsa Garehgholi
Ibn Sina Street, Doctora Crossroads, University Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Gharehgm981@mums.ac.ir Mashhad University of Medical Sciences scientific Seyed Reza Mazloum
Ibn Sina Street, Doctora Crossroads, University Street
Mashhad Iran (Islamic Republic of) 9137913199 05138598019-207 mazlomr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age above 18 years Having consent to study Having minimum reading and writing literacy to complete the questionnaire Patients diagnosed with type 2 diabetes for at least 6 months Diagnosis of the disease by a specialist Having a smartphone and being able to use it 18 years no limit Both Having another chronic disease as diagnosed by a doctor Mental illness diagnosed by a doctor Having a complication caused by diabetes such as diabetic neuropathy E11 Type 2 diabetes mellitus Behavior Behavior Intervention group 1: In this group, self-care training is done face-to-face during three one-hour sessions at intervals of one week. The patients are placed in groups of 6 to 8 people and the researcher will provide necessary information related to self-care training (nutrition management, drug management, activity management, and blood sugar check). Intervention group 2: In this group, self-care training conducted for three months through a smartphone application. This application includes specific training in the field of self-care for type 2 diabetes patients (nutrition and activity management, medication management, and blood sugar check). This app is a type of educational app that has self-care educational facilities (text, audio, and video) and important titles are presented in a highlighted form. It is also possible to communicate with the researcher in the form of text, and the patient will receive his answer after sending the question, and if he goes online, he will be able to learn new materials. After designing and building the above application, in a 15-20 minute session, the application will be installed on the phone and necessary explanations will be given to the patients regarding how to use it. Two weeks after the application is installed, the patients will be contacted and the ability and efficiency of the application will be evaluated. Adherence to the treatment regimen. Timepoint: Before and 3 months after the intervention. Method of measurement: Questionnaire of adherence to the treatment of chronic diseases. Glycosylated hemoglobin. Timepoint: Before and 3 months after the intervention. Method of measurement: Glycosylated hemoglobin test. Mashhad University of Medical Sciences Approved 2022-08-02 Ethics Committee of Faculty of Nursing and Midwifery - Mashhad University of Medical Sciences Qurashi Building, Near Hovaze Cinema, Daneshgah St, Mashhad, Khorasan Razavi, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)