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IRCT20231227060543N1 IRCT 2024-01-17 Jahrom University of Medical Sciences effect of medication self-management intervention based on the 5A model on medication adherence and quality of life of myocardial infarction patients Investigating the effect of medication self-management intervention based on the 5A model on medication adherence and quality of life of myocardial infarction patients hospitalized in Jahrom medical sciences hospitals 2024-01-21 anticipated 66 Complete https://irct.ir/trial/74696 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples will be randomly assigned to two intervention and control groups in such a way that the letters A and B will be written on small cards, and kept in a closed envelope. At the beginning of each week, the door of one of the envelopes is randomly opened and based on the writing on the card, it will be determined that during that week, the samples will be placed in the intervention or control group, Blinding description: The samples will be assigned to two intervention and control groups in such a way that the letters A and B will be written on small cards, and kept in a closed envelope. At the beginning of each week, the door of one of the envelopes is randomly opened and based on the writing on the card, it will be determined that during that week, the samples will be placed in the intervention or control group. Patients do not know about the interventions performed for the other group, and which group they belong to. This intervention is performed by the researcher himself, so the researcher is not blinded. N/A Myocardial infarction. Intervention 1: "Intervention group" After each patient is randomly assigned in two Test and control groups, the demographic information questionnaire, the morrisky drug compliance questionnaire, the quality of life questionnaire, will be completed by each patient before the intervention is performed. Then the drug self-management intervention will begin for patients of the intervention group, which will use face-to-face training and Q & A.The planned educational content for the intervention group includes a program to promote drug self-management (information related to medications taken, long-term drug regimen compliance, drug complications, and disease management). The intervention follows the following steps in five face-to-face sessions on the second and third days of hospitalization in two shifts in the morning and evening and in the shift when discharging patients for each participant of the intervention group, which will be presented for 20 minutes in the patient's clinic in the hospital by creating a private environment. But this period can be extended based on the needs of patients. After discharge, 8 phone calls will also be made to follow up on patients. In the first two weeks, the phone call will be made three days in between(twice a week) and after two weeks, for four weeks, once a week until the end of the intervention period. The intervention will be implemented on the following basis(self-management model 5A).Review stage: at this stage, the patient will be examined in person in terms of the history of the disease, the underlying disease, the recognition of previous medications, the use of medications, the occurrence of drug complications.Guidance stage: at this stage, based on the results of previous stage studies, the risks of drug non-compliance diagnosed will be communicated to the patient and the benefits of behavior change will be emphasized. The importance of controlling the disease, the importance of taking medicines and the diet, and the consequences of not taking medicines are discussed, and the patient is encouraged to express his experiences of taking medicines and build trust. The benefits and importance of drug compliance in preventing disease complications will be explained.Agreement stage: a written agreement on the patient's performance will be made to set goals between the patient and the researcher. According to the diagnosed problems, appropriate and agreed goals will be set with the patient and an action plan will be drawn up for each of the goals.(For example, in patients who arbitrarily discontinue the drug by observing signs of recovery, the risks of not taking the drug and its importance to health will be explained, and a written agreement will be made between the patient and the researcher regarding the timely use of the drug and the time of its use.)Assistance phase: this phase involves cooperation in the development of the action plan(compliance with drug therapy). At this stage, which will be done during the shift during discharge, the patient will be given face-to-face training to teach about the medication regimen during discharge and control of his vital signs, and will be practiced. At this stage, training will be held with the aim of promoting patient awareness of medicines and providing patient and researcher experience, in which previous training materials will be reviewed. Care for medications and possible complications will also be expressed again.Performance follow-up: at this stage, patients ' performance will be followed up for 6 weeks. To ensure the implementation of action plans by patients, the first two weeks will be followed up by phone calls three days in between and after two weeks, for four weeks, once a week until the end of the intervention period. The calls will review the agreed action plan and objectives, and if necessary if changes are needed to the objectives and / or action plan will be made by re-agreement. Then at the end of the intervention, the variables of drug compliance and quality of life will be measured in two groups, and if necessary, if changes are needed in the objectives or action plan, the necessary changes will be applied by re-agreement. Then at the end of the intervention(at the end of the sixth week), the questionnaire on drug compliance and quality of life will be asked again by telephone and completed. Intervention 2: Control group: "Patients in the control group" will fill in the medication compliance and quality of life questionnaire in the hospital and will only receive the usual care in their care and treatment process. Then, at the end of the intervention (at the end of the sixth week), the medication compliance and quality of life questionnaire will be administered by telephone again. will be asked and completed. 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 Heydari Aghcheghlo
University of Medical Sciences., pardis site., Ostad Motahari Blvd., Jahrom town
Jahrom Iran (Islamic Republic of) ۷۴۱۳۱۸۸۹۴۱ 007154372252 mahsa.206772@gmail.com Jahrom University of Medical Sciences scientific Zohreh Badiyepeymaie Jahromi
University of Medical Sciences., pardis site., Ostad Motahari Blvd., Jahrom town
Jahrom Iran (Islamic Republic of) ۷۴۱۳۱۸۸۹۴۱ 007154372252 z.badiyepeyma@gmail.com Jahrom University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Literacy Age range between 30 and 65 years Diagnosis of myocardial infarction by a doctor Have no previous history of myocardial infarction Hospitalized patients for at least three days Having one of the diseases of blood pressure diabetes or hyperlipidemia that they have taken for at least six months The ability to perform self-care, especially the consumption and adherence to the medication regimen Ability to prepare and buy prescribed drugs The patient's non-participation in other educational plans of self-care methods 30 years 65 years Both Patient death during the study Non-participation of the patient in telephone follow-up and questionnaire completion I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Lifestyle Lifestyle "Intervention group" After each patient is randomly assigned in two Test and control groups, the demographic information questionnaire, the morrisky drug compliance questionnaire, the quality of life questionnaire, will be completed by each patient before the intervention is performed. Then the drug self-management intervention will begin for patients of the intervention group, which will use face-to-face training and Q & A.The planned educational content for the intervention group includes a program to promote drug self-management (information related to medications taken, long-term drug regimen compliance, drug complications, and disease management). The intervention follows the following steps in five face-to-face sessions on the second and third days of hospitalization in two shifts in the morning and evening and in the shift when discharging patients for each participant of the intervention group, which will be presented for 20 minutes in the patient's clinic in the hospital by creating a private environment. But this period can be extended based on the needs of patients. After discharge, 8 phone calls will also be made to follow up on patients. In the first two weeks, the phone call will be made three days in between(twice a week) and after two weeks, for four weeks, once a week until the end of the intervention period. The intervention will be implemented on the following basis(self-management model 5A).Review stage: at this stage, the patient will be examined in person in terms of the history of the disease, the underlying disease, the recognition of previous medications, the use of medications, the occurrence of drug complications.Guidance stage: at this stage, based on the results of previous stage studies, the risks of drug non-compliance diagnosed will be communicated to the patient and the benefits of behavior change will be emphasized. The importance of controlling the disease, the importance of taking medicines and the diet, and the consequences of not taking medicines are discussed, and the patient is encouraged to express his experiences of taking medicines and build trust. The benefits and importance of drug compliance in preventing disease complications will be explained.Agreement stage: a written agreement on the patient's performance will be made to set goals between the patient and the researcher. According to the diagnosed problems, appropriate and agreed goals will be set with the patient and an action plan will be drawn up for each of the goals.(For example, in patients who arbitrarily discontinue the drug by observing signs of recovery, the risks of not taking the drug and its importance to health will be explained, and a written agreement will be made between the patient and the researcher regarding the timely use of the drug and the time of its use.)Assistance phase: this phase involves cooperation in the development of the action plan(compliance with drug therapy). At this stage, which will be done during the shift during discharge, the patient will be given face-to-face training to teach about the medication regimen during discharge and control of his vital signs, and will be practiced. At this stage, training will be held with the aim of promoting patient awareness of medicines and providing patient and researcher experience, in which previous training materials will be reviewed. Care for medications and possible complications will also be expressed again.Performance follow-up: at this stage, patients ' performance will be followed up for 6 weeks. To ensure the implementation of action plans by patients, the first two weeks will be followed up by phone calls three days in between and after two weeks, for four weeks, once a week until the end of the intervention period. The calls will review the agreed action plan and objectives, and if necessary if changes are needed to the objectives and / or action plan will be made by re-agreement. Then at the end of the intervention, the variables of drug compliance and quality of life will be measured in two groups, and if necessary, if changes are needed in the objectives or action plan, the necessary changes will be applied by re-agreement. Then at the end of the intervention(at the end of the sixth week), the questionnaire on drug compliance and quality of life will be asked again by telephone and completed. Control group: "Patients in the control group" will fill in the medication compliance and quality of life questionnaire in the hospital and will only receive the usual care in their care and treatment process. Then, at the end of the intervention (at the end of the sixth week), the medication compliance and quality of life questionnaire will be administered by telephone again. will be asked and completed. Medication adherence score in Morisky questionnaire. Timepoint: Measurement of medication adherence at the beginning of the study (before the start of the intervention) and six weeks after the start of the intervention. Method of measurement: Moriski medication adherence questionnaire. Quality of life score. Timepoint: At the beginning of the study (before the start of the intervention) and six weeks after the start of the intervention. Method of measurement: Mac New Quality of Life Questionnaire. Jahrom University of Medical Sciences Approved 2023-12-23 Ethics committee of Jahrom university of Medical Sciences Jahrom University of Medical Sciences - campus site, Ostad Motahari St., Jahrom town Jahrom Fars Iran (Islamic Republic of)