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IRCT20230808059079N1 IRCT 2023-08-19 Shaheed Rajaie Cardiovascular, Medical & Research Center Self-care training in patients with advanced heart failure Comparison the effect of self-care education by teach back and multimedia method on the level of self-care, quality of life and readmission of patients with advanced heart failure 2023-09-21 anticipated 120 Complete https://irct.ir/trial/71913 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: According to the inclusion criteria, patients with advanced heart failure will be divided into three groups of 40 people based on randomization using random blocks of size 6, and the patients will be allocated to each of the two teachback and multimedia intervention groups and A control group is performed. In this way, 20 blocks of 6 by computer program CREATE A RANDOMISATION LIST will be created. (https://www.sealedenvelope.com/simple-randomiser/v1/lists) and then the samples will be placed in one of the groups in the order provided by this program (an example of a sequence of random numbers in each It consists of 6 blocks: AABBCC, ABCABC, ABACBC, ACBCAB, etc.). N/A Condition 1: heart failure. Condition 2: Left ventricular failure. Condition 3: Systolic (congestive) heart failure. Condition 4: Heart failure, unspecified. Condition 5: Diastolic (congestive) heart failure. Condition 6: Combined systolic (congestive) and diastolic (congestive) heart failure. Condition 7: Acute systolic (congestive) heart failure. Condition 8: Chronic systolic (congestive) heart failure. Condition 9: Acute diastolic (congestive) heart failure. Condition 10: Chronic diastolic (congestive) heart failure. Condition 11: Acute on chronic diastolic (congestive) heart failure. Intervention 1: The first intervention group: Self-care training in advanced heart failure patients using teach back method, 40 of these patients were trained by the researcher in the evening of two consecutive days for one hour each time in the ward where the patient is hospitalized and at the patient's bed during hospitalization. And they will receive face-to-face, interactive, question and answer, repetition and practice. After two one-hour training sessions, a pamphlet with the same content taught to the patients will be presented. The patient will be followed up by the researcher for one month after discharge, so that the researcher will call the patient once a week and review the educational content by phone and based on teach back . Self-care education includes the description of heart function, definition of heart failure, The causes and symptoms of this disease and its treatment control, drug treatment tips, diet tips, fluid intake, daily note of fluid intake and daily urine volume, how to perform physical activity, daily weighing, training to avoid smoking and alcohol consumption, annual injection Flu vaccine and other health and safety tips. Intervention 2: The second intervention group: self-care training in advanced heart failure patients by multimedia method, 40 of these patients, training by the researcher in the evening of two consecutive days for one hour each time in the ward where the patient is hospitalized and at the patient's bedside. They will receive the prepared multimedia (film, image, audio, text, moving images, etc.) individually with the same conditions by laptop, and at the end, if the patients have any questions, they will be answered. The training content will be sent to this group in the form of a link by SMS, and the patients will receive the same multimedia training content by opening this link. This link includes the content of the self-care program: the nature of heart failure disease, its causes and manifestations, exercise and physical activity, drugs, diet, safety and health tips and lifestyle, which are presented in two sessions at the patient's bedside in the form of video, photos, audio, The text, moving images will be played, and this link will be made with the help of respected professors and advisors. After the last training session, the patient will be monitored for one month and the researcher will follow up once a week to review the multimedia content through the link sent. Intervention 3: Control group: 40 patients with advanced heart failure will receive the department's routine training including diet, activity, bathing, daily weight control, how to take medications in the form of a two-page training booklet by the department's nurses. Yes - There is a plan to make this available What will be shared: Part of the data, such as the information related to the main outcome, can be shared. When: The access period starts 6 months after the results are published To whom: For researchers working in academic and scientific institutions Conditions: For the use of researchers and people who decide to help correct the lifestyle of people with advanced heart failure. Where to obtain: E-mail: mahsa.satari.gh@gmail.com How to obtain: Finally, the documents will be sent within two weeks. Comments:
public mahsa satari gholami
Shaheed Rajaie Cardiovascular Medical and Research Center , Valiasr Ave Niayesh Intersection
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 mahsa.satari.gh@gmail.com Shaheed Rajaie Cardiovascular, Medical & Research Center scientific fiadan shabani
Shaheed Rajaie Cardiovascular Medical and Research Center , Valiasr Ave Niayesh Intersection
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 ‫fidannahal@yahoo.com Shaheed Rajaie Cardiovascular, Medical & Research Center Iran (Islamic Republic of) Age 18 to 65 years Patient alertness Minimum literacy Having advanced heart failure according to the diagnosis of a cardiologist and EF less than 30% Not having a history of mental disorders based on the patient's self-report Not having an education in the department of medical sciences Not having speech, hearing, cognitive and memory defects Having a smart mobile phone and being able to use it 18 years 65 years Both The patient's unwillingness to continue participating in any stage of the research It is not possible to communicate by phone during the follow-up period death of the patient I50 I50.1 I50.2 I50.9 I50.3 I50.4 I50.21 I50.22 I50.31 I50.32 I50.33 Heart failure Left ventricular failure Systolic (congestive) heart failure Heart failure, unspecified Diastolic (congestive) heart failure Combined systolic (congestive) and diastolic (congestive) heart failure Acute systolic (congestive) heart failure Chronic systolic (congestive) heart failure Acute diastolic (congestive) heart failure Chronic diastolic (congestive) heart failure Acute on chronic diastolic (congestive) heart failure Lifestyle Lifestyle Lifestyle The first intervention group: Self-care training in advanced heart failure patients using teach back method, 40 of these patients were trained by the researcher in the evening of two consecutive days for one hour each time in the ward where the patient is hospitalized and at the patient's bed during hospitalization. And they will receive face-to-face, interactive, question and answer, repetition and practice. After two one-hour training sessions, a pamphlet with the same content taught to the patients will be presented. The patient will be followed up by the researcher for one month after discharge, so that the researcher will call the patient once a week and review the educational content by phone and based on teach back . Self-care education includes the description of heart function, definition of heart failure, The causes and symptoms of this disease and its treatment control, drug treatment tips, diet tips, fluid intake, daily note of fluid intake and daily urine volume, how to perform physical activity, daily weighing, training to avoid smoking and alcohol consumption, annual injection Flu vaccine and other health and safety tips. The second intervention group: self-care training in advanced heart failure patients by multimedia method, 40 of these patients, training by the researcher in the evening of two consecutive days for one hour each time in the ward where the patient is hospitalized and at the patient's bedside. They will receive the prepared multimedia (film, image, audio, text, moving images, etc.) individually with the same conditions by laptop, and at the end, if the patients have any questions, they will be answered. The training content will be sent to this group in the form of a link by SMS, and the patients will receive the same multimedia training content by opening this link. This link includes the content of the self-care program: the nature of heart failure disease, its causes and manifestations, exercise and physical activity, drugs, diet, safety and health tips and lifestyle, which are presented in two sessions at the patient's bedside in the form of video, photos, audio, The text, moving images will be played, and this link will be made with the help of respected professors and advisors. After the last training session, the patient will be monitored for one month and the researcher will follow up once a week to review the multimedia content through the link sent. Control group: 40 patients with advanced heart failure will receive the department's routine training including diet, activity, bathing, daily weight control, how to take medications in the form of a two-page training booklet by the department's nurses. Self-care score. Timepoint: Before the start of the intervention, 30 days after the intervention. Method of measurement: European questionnaire of self-care behavior in heart failure. Quality of life score. Timepoint: Before the start of the intervention, 30 days after the intervention. Method of measurement: Questionnaire of the quality of life of Minnesota heart failure patients. Readmission due to heart failure (Number of readmissions). Timepoint: One month after the patient's discharge. Method of measurement: Verbal interview with the patient/check through the hospital's HIS system. Not available. Timepoint: Not available. Method of measurement: Not available. Shaheed Rajaie Cardiovascular, Medical & Research Center Approved 2023-08-05 Ethics Committee of Shahid Rajaei Cardiovascular Medical Research Training Center NO. 120, pars Building, marvdasht street, moalem street, shariati street, tehran Tehran Tehran Iran (Islamic Republic of)