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IRCT20130801014242N4 IRCT 2023-06-16 Esfahan University of Medical Sciences The effect of the 5 A self-management model on the understanding of the facts of heart diseases and adherence to treatment regimen Investigating the effect of implementing the 5A self-management model on the understanding of the facts of heart diseases and adherence to the treatment regimen in patients with type 2 diabetes under the comprehensive health service centers of Isfahan 1402 2023-06-20 anticipated 70 Complete https://irct.ir/trial/69828 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization will be done in three stages. In the first stage, between Isfahan health network one and Two, one of the centre's number one or two will be chosen randomly (tossing a coin) and then the list of comprehensive health service centres of this centre will be prepared. In the second stage, a centre will be selected by lottery as the intervention group, and the control group to be homogenous in terms of social and economic conditions with the subjects of the intervention centre, among the comprehensive health service centres listed in the vicinity of the centre of the intervention group, A centre will be selected as a control group by drawing lots. In the third stage, in the centres selected by the researcher, through the Sib system, the head of the centre will prepare a list of all the people who meet the criteria for entering the study and will systematically select the subjects, in such a way that first, the total number of the population Divide the research by the required number of subjects to get the K number. Then randomly, the first number below ten is obtained, which is called n. Then the numbers N+K, N+2K, N+3K,... will be selected until the last subject. N/A Type 2 diabetes. Intervention 1: Intervention group: Before starting the study, the intervention group completed demographic questionnaires, understanding the facts of heart diseases and adhering to the treatment regimen, and for them, a self-management program based on the 5A model is implemented in 5 stages. The 5 stages include examination, guidance, agreement, help and follow-up. The first 3 stages will be held individually and the 4th stage will be held in groups of 8 to 12 people for 1 to 2 hours in the form of peer group training. The follow-up stage will also be done by phone. At the end (immediately and two months after the intervention), the questionnaires on understanding the facts of cardiovascular diseases and adherence to the treatment regimen will be completed again in the intervention group. Intervention 2: Control group: Control group: Before starting the study, the control group will complete demographic questionnaires, understand the facts of heart diseases and adhere to the treatment regimen, and will receive the usual care. At the end (immediately and two months after the intervention), the questionnaires of understanding the facts of cardiovascular diseases and adherence to the treatment regimen will be completed again in the control group. After the intervention, at the end of the study, the educational content will be provided to the control group and a training session will be held for 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 Maryam Shirazi
Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 1792 2904 m_shirazi@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Maryam Shirazi
Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 1792 2904 m_shirazi@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Be Persian speaking. At least one year has passed since the definitive diagnosis of type 2 diabetes Do not have any underlying disease that hinders speech and understanding, including cognitive, visual, and motor sensory diseases such as severe depression, mental retardation, and Parkinson's. Have minimum reading and writing literacy. Have an active file in comprehensive health service centers of Isfahan city. Be Iranian. 40 years 65 years Both Aggravation of the disease from the time of the phone call to the time of attending the center to complete the questionnaires and perform the intervention that leads to hospitalization or death of the samples. Cardiovascular diseases The patient does not want to cooperate in the study. E11 Type 2 diabetes mellitus Treatment - Other Treatment - Other Intervention group: Before starting the study, the intervention group completed demographic questionnaires, understanding the facts of heart diseases and adhering to the treatment regimen, and for them, a self-management program based on the 5A model is implemented in 5 stages. The 5 stages include examination, guidance, agreement, help and follow-up. The first 3 stages will be held individually and the 4th stage will be held in groups of 8 to 12 people for 1 to 2 hours in the form of peer group training. The follow-up stage will also be done by phone. At the end (immediately and two months after the intervention), the questionnaires on understanding the facts of cardiovascular diseases and adherence to the treatment regimen will be completed again in the intervention group. Control group: Control group: Before starting the study, the control group will complete demographic questionnaires, understand the facts of heart diseases and adhere to the treatment regimen, and will receive the usual care. At the end (immediately and two months after the intervention), the questionnaires of understanding the facts of cardiovascular diseases and adherence to the treatment regimen will be completed again in the control group. After the intervention, at the end of the study, the educational content will be provided to the control group and a training session will be held for this group. Adherence to treatment regimen score in the Modanlo questionnaire/Score of understanding the facts of heart diseases in the Wegener heart disease facts questionnaire. Timepoint: At the beginning of the study, immediately and 2 months after the start of the intervention. Method of measurement: Questionnaires of the facts of Wegener's heart disease and adherence to Modanlo's treatment regimen. Esfahan University of Medical Sciences Approved 2023-05-13 Ethics Committee of Isfahan University of Medical Sciences Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hazar Jarib Street Isfahan Isfehan Iran (Islamic Republic of)