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IRCT20221029056335N1 IRCT 2023-06-17 Ilam University of Medical Sciences Investigating the effect of education on the self-efficacy of patients with diabetes Effect of education on self-efficacy and diabetes-related outcomes in patients with type 1 diabetes: A follow-up care model based on online messaging service 2023-06-10 anticipated 96 Complete https://irct.ir/trial/66569 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After baseline assessment eligible patients will randomly be assigned to one of two treatment groups using permuted block randomization with allocation concealment. Block randomization will be conducted by Random Allocation Software 2.0, with a block size of four, and an allocation ratio of 1:1. The main use of Random Allocation Software is to produce simple or block randomized sequences for parallel group trials. Participants will be sequentially allocated to the treatments in the order in which they were recruited. Intervention assignment will be ascertained using sealed, opaque envelopes with consecutive numbering. The investigator who opens the envelopes and implements assignments will not be involved in the generation and allocation concealment. Due to the nature of the intervention, patients and the study researchers will be aware of the allocated treatment, Blinding description: Due to the nature of the intervention, neither participants nor researchers can be blinded. This is a single-blinded study. The assessor (who will assess the outcome measures) and the data analyzer will be blind. N/A Type 1 diabetes. Intervention 1: Intervention Group: The education intervention package consisted of text, educational illustrations, and movie clips. The intervention content is based on the Iranian Ministry of Health Guideline on the management of type 1 diabetes which involves education on self-care management, lifestyle modification (including diet, physical activity, monitoring), and medications. This education will be provided on an individual basis using online messaging applications (Sorush, Gap, Ita, Baleh, WhatsApp, and Telegram). The intervention group will receive 36 sessions of type 1 diabetes education within 12 weeks, three times per week. Each education session will last 10 minutes. In addition, the researcher will provide one follow-up call every two weeks to participants in the experimental group. The length of each call will be varies depending on the participant. All telephone calls will be arranged at the participants` convenience times. The purpose of calling is to foster continued performance accomplishment via verbal persuasion and answering participants' questions (if any). In addition, Telephone follow-up will provide continuous enhancement skills fostering, goal-setting sharing, and mental support for diabetics. Intervention 2: Control group: They will receive routine care related to type 1 diabetes and no additional education will be delivered to this group. 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 Mohammad Amir Sadeghi
No 4, Zakaria Steet., Sanaye Blvd
Ilam Iran (Islamic Republic of) 6931345715 +98 84 3222 5234 Mamirsadeghi96@gmail.com Ilam University of Medical Sciences scientific Mohammad Amir Sadeghi
No 4, Zakaria Steet., Sanaye Blvd
Ilam Iran (Islamic Republic of) 6931345715 +98 84 3222 5234 Mamirsadeghi96@gmail.com Ilam University of Medical Sciences Iran (Islamic Republic of) Being clinically diagnosed with type 1 diabetes Mellitus at least 6 months, Age range 18-65 years, Willingness to participate in the research, No medical history of having cognitive deficits or mental illness, No acute medical condition in the last 6 months, Having the ability to read and write Persian, Have a mobile phone and be able to use it 18 years 65 years Both Have type 1 diabetes combined with severe complications which would interfere with self-care such as DKA, heart attack, and angina, Have hemolytic anemias, hemoglobinopathies, Known hearing impairment, Known vision impairment, Unable to participate in the education program (for example are housebound or are participating in another research study). E08 Diabetes mellitus due to underlying condition Lifestyle Lifestyle Intervention Group: The education intervention package consisted of text, educational illustrations, and movie clips. The intervention content is based on the Iranian Ministry of Health Guideline on the management of type 1 diabetes which involves education on self-care management, lifestyle modification (including diet, physical activity, monitoring), and medications. This education will be provided on an individual basis using online messaging applications (Sorush, Gap, Ita, Baleh, WhatsApp, and Telegram). The intervention group will receive 36 sessions of type 1 diabetes education within 12 weeks, three times per week. Each education session will last 10 minutes. In addition, the researcher will provide one follow-up call every two weeks to participants in the experimental group. The length of each call will be varies depending on the participant. All telephone calls will be arranged at the participants` convenience times. The purpose of calling is to foster continued performance accomplishment via verbal persuasion and answering participants' questions (if any). In addition, Telephone follow-up will provide continuous enhancement skills fostering, goal-setting sharing, and mental support for diabetics. Control group: They will receive routine care related to type 1 diabetes and no additional education will be delivered to this group. Self-efficacy. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Sharr General Self-Efficacy Questionnaire. Adherence to treatment. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: medanlo Questionnaire of adherence to treatment. Self care. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Tobert self-care questionnaire. Ilam University of Medical Sciences Approved 2022-10-24 Ethics committee of ilam University of Medical Sciences Pazhohesh blvd ,Ilam University of Medical Sciences ,Ilam Ilam Ilam Iran (Islamic Republic of)