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IRCT20210302050555N1 IRCT 2021-03-28 Tehran University of Medical Sciences The Effect of mobile-learning on stress and self-efficacy among diabetes patients with covid-19 The Effect of mobile-learning on stress and self-efficacy among diabetes patients with covid-19 2021-04-21 anticipated 70 Complete https://irct.ir/trial/54915 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Blocking randomization First, I go to the hospitals with an official introduction letter. A master list of all eligible people will be prepared and will be placed in the intervention and control group by blocking randomization method. Based on the results of studies, the number of required samples in each group is equal to 31 people in each group; taking into account of the 10% drop, the final number of required samples in each group is equal to 35. Total of 70 diabetic people with Covid-19 are determined are allocated by block randomization method into intervention and control groups. In the present study, the number of blocks will be 4 blocks. The adequacy of the number of samples in the early stages of this study is re-evaluated, Blinding description: This is a single blind research. After explanation and clarification all steps to participants and obtaining written consent; the study will be started. N/A Condition 1: covid-19. Condition 2: diabetes. Intervention 1: Intervention group: After completing the informed consent form to participate in the study and completing the desired questionnaires (demographic information questionnaire, perceived stress questionnaire and diabetes self-efficacy questionnaire) by phone call; During three months, three educational contents per week between 8 and 12 AM, including motivational items, daily care, healthy lifestyle, nutrition, exercise, warning signs or complications about covid-19 and diabetes will be provided based on the preferred method of each (Phone call or text message). At the end of the intervention, the questionnaires will be completed again by phone call. Intervention 2: Control group: After completing the informed consent form to participate in the study and completing the desired questionnaires (demographic information questionnaire, perceived stress questionnaire and diabetes self-efficacy questionnaire) by phone cal; Welcome and study entry SMS will send to control group. During three months, in the first week of each month, they recieve phone call in order to greet and not to lose samples. At the end of the intervention, in order to observe the ethics in the research, the presented content will be provided to the control group in the form of a CD. 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 more information.
public Sara Abbasian
No.9, Ashkshahr St., Jahanara Ave., Yousefabad
Tehran Iran (Islamic Republic of) 1438913118 +98 21 8800 3661 s-abbasian@razi.tums.ac.ir Tehran University of Medical Sciences scientific Sara Abbasian
No.9, Ashkshahr St., Jahanara Ave., Yousefabad
Tehran Iran (Islamic Republic of) 1438913118 +98 21 8800 3661 s-abbasian@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of type one or type two diabetes by a specialist. Detection of covid-19 based on positive PCR test. Age range 18-65 year old. Basic literacy(able to read and write). Having mobile phone. Living in Tehran. 18 years 65 years Both Having any disease that interfere with the research process like psychological problems, stroke, heart attack, ketoacidosis. Re-infection by covid-19. U07.2 E08 COVID19, virus not identified Diabetes mellitus due to underlying condition Rehabilitation N/A Intervention group: After completing the informed consent form to participate in the study and completing the desired questionnaires (demographic information questionnaire, perceived stress questionnaire and diabetes self-efficacy questionnaire) by phone call; During three months, three educational contents per week between 8 and 12 AM, including motivational items, daily care, healthy lifestyle, nutrition, exercise, warning signs or complications about covid-19 and diabetes will be provided based on the preferred method of each (Phone call or text message). At the end of the intervention, the questionnaires will be completed again by phone call. Control group: After completing the informed consent form to participate in the study and completing the desired questionnaires (demographic information questionnaire, perceived stress questionnaire and diabetes self-efficacy questionnaire) by phone cal; Welcome and study entry SMS will send to control group. During three months, in the first week of each month, they recieve phone call in order to greet and not to lose samples. At the end of the intervention, in order to observe the ethics in the research, the presented content will be provided to the control group in the form of a CD. Stress. Timepoint: measuring stress level will be done before the intervention & 3 months after beginning of the intervention. Method of measurement: Cohen's perceived stress questionnaire. Self-efficacy in diabetes. Timepoint: measuring self-efficacy level will be done before the intervention & 3 months after beginning of the intervention. Method of measurement: Diabetes self-efficacy questionnaire. Tehran University of Medical Sciences Approved 2021-03-09 Ethics committee of Tehran University of Medical Science Nursing and midwifery department of Tehran University of Medical Science, Nosrat St., Enqelab Sq., Tehran, Tehran Tehran Iran (Islamic Republic of)