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IRCT20210416050992N1 IRCT 2021-05-30 Tehran University of Medical Sciences Effect of BEHZEE APP on medical adherence and self-care The effect of BEHZEE diabetic mobile application on medical adherence and self-care in patients with diabetes mellitus type 2 2021-06-05 anticipated 130 Complete https://irct.ir/trial/56230 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Patients will be selected by available method from diabetic patients referred to the hospitals of Tehran University of Medical Sciences. Selected samples with random allocation will be divided into two intervention and control groups . This method is used to prevent significant imbalances in the number of participants assigned to each group. Block randomization ensures that no significant imbalance is established between groups at any time during randomization, and at certain points the number of participants in each group is equal. Blocks of 4 will be considered to complete the sample size. Then the list of blocks will be written and the numbers will be assigned to them: AABB (1) - ABAB (2) -ABBA (3) - BBAA (4) - BABA (5) - BAAB (6). For this purpose, all possible modes for quadruple blocks will be determined as 2 items in the test group and 2 items in the control group (6 modes in total). Then the numbers will be selected from a table of random numbers and the allocation of individuals in the test and control groups will be done as follows. Dark envelopes will be used to conceal the allocation. N/A Type 2 diabetes. Intervention 1: Intervention group: Within 3 months, the intervention team will receive and implement lifestyle recommendations in 7 key areas recommended for better diabetes self-care recommended by the American Diabetes Educators Association:1. Recommendations for type 2 diabetes management training, 2. Adequate mobility and use of all muscles in the body 3. Proper nutrition in this disease 4. Proper and continuous use of drugs prescribed by a doctor and adaptation to them 5. Sleep and rest in type 2 diabetes 6. Management of interaction with the environment and reduction of high-risk behaviors, appropriate to the disease 7. How to manage and promote mental health in this disease. Intervention 2: Control group: The control group receives all the recommendations as a printed file when they go to the hospital and enter the study, but no interactive training such as questions and answers is done with them and only to answer questions Logs in to complete the questionnaires through the application. Yes - There is a plan to make this available What will be shared: The main data of the study can be shared after being unidentifiable through contacting with correspond conductor of this study When: Starting after publication To whom: Data is only available for people working in academic institutions Conditions: It is essential to agree on the type of use and purpose of the data access request when submitting the request. Where to obtain: Through the following email address: s-poortaghi@sina.tums.ac.ir How to obtain: Mention the purpose of the request Mention the type of data usage Access to data at least one month after receiving the request Comments:
public Mohammad salehpoor emran
No. 52, Vesal Shirazi Dormitory, Italy Intersection, Vesal St., Enghelab Square
Tehran Iran (Islamic Republic of) 1417743855 +98 11 3533 9265 ms_82820@yahoo.com Tehran University of Medical Sciences scientific mohammad salehpoor emran
No. 52, Vesal Shirazi Dormitory, Italy Intersection , Vesal St. , Enghelab Square
Tehran Iran (Islamic Republic of) 1417743855 +98 11 3533 9265 ms_8280@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) HgA1C level higher or equal to 8% Be literate Ability to use cell phone Diagnosed type 2 diabetes at least one year ago 18 years no limit Both Not intention to continue participation Absence in more than two educational sessions hospitalization due to new complication during the intervention E08 Diabetes mellitus due to underlying condition Lifestyle Lifestyle Intervention group: Within 3 months, the intervention team will receive and implement lifestyle recommendations in 7 key areas recommended for better diabetes self-care recommended by the American Diabetes Educators Association:1. Recommendations for type 2 diabetes management training, 2. Adequate mobility and use of all muscles in the body 3. Proper nutrition in this disease 4. Proper and continuous use of drugs prescribed by a doctor and adaptation to them 5. Sleep and rest in type 2 diabetes 6. Management of interaction with the environment and reduction of high-risk behaviors, appropriate to the disease 7. How to manage and promote mental health in this disease. Control group: The control group receives all the recommendations as a printed file when they go to the hospital and enter the study, but no interactive training such as questions and answers is done with them and only to answer questions Logs in to complete the questionnaires through the application. Self-care of diabetic patients. Timepoint: Before the intervention and 3 months after it. Method of measurement: Diabetes self-care questionnaire. Drug adherence. Timepoint: Before the intervention and 3 months after it. Method of measurement: Morisky Drug Adherence Questionnaire. Fasting blood sugar. Timepoint: Before the intervention and three months after. Method of measurement: Mg / dl. HbA1C. Timepoint: Before and 3 months after intervention. Method of measurement: Blood Sample. Tehran University of Medical Sciences Approved 2021-05-01 Joint Organizational Ethics Committee of the School of Nursing, Midwifery and Rehabilitation, Tehran School of Nursing and Midwifery, Tohid Square Tehran Tehran Iran (Islamic Republic of)