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IRCT20250123064495N2 IRCT 2025-08-10 Shahre-kord University of Medical Sciences The effect of personalized self-management in patients with heart failure The Effect of Personalized Self-management Program on Self-Care and Rehospitalization of Inpatients with Heart Failure 2025-09-17 anticipated 84 Complete https://irct.ir/trial/84199 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: This study will be conducted in two university hospitals with 84 participants. The samples will be selected from inpatients in the cardiac and internal medicine departments of educational hospitals in Shahrekord using convenience sampling. Eligible patients will be divided into two groups using the block randomization method: intervention (A) and control (B). The randomized block procedure will be performed as follows: 1) All possible block states -created with the combination of AAABBB - labeling: AAABBB, ABBABA, BABABA, etc. will be written, 2) Written blocks will be provided in sealed envelopes, 3) One of the envelope will be be selected by a neutral person, and the six-letter combination will be noted down and then placed back in the box, 4) This process will be repeated 14 times to achieve a sequence of letters from 1 to 84, 5) Numbers from 1 to 84 will be assigned to each letter (A, B), and these numbers written on sealed envelopes. 6) At the beginning of sampling, the sealed envelopes will be opened and assigned to the patients. Participants will be randomly assigned to the intervention group or the control group according to the selected letters. N/A Heart failure. Intervention 1: Intervention group: After completing the questionnaires and reviewing their information, educational sessions will be held for a total of 60 minutes (in 3 consecutive daily sessions). The first session will be conducted face-to-face, with the patient's family member present, and the researchers will answer their questions. In the first session, only the contents of the general information booklet will be reviewed. In the next two sessions, which will be held virtually, in addition to reviewing the most important previous materials, a personalized pamphlet, tailored to each individual, will be reviewed with the patient. All developed educational materials will be derived from each patient's questionnaires, including adhering to recommended diet based on the patient's weight, regulation of activities (depending on age, gender, occupation, ejection fraction of the heart and stage of the disease), adherence to the medication regime and familiarisation with side effects, control of smoking based on individual habits, recognition of disease symptoms and adherence to training. If the patient is discharged during this period, the training will be conducted virtually by the researchers. To ensure that patients understand the material, all patients will receive an educational pamphlet, and researchers will receive regular feedback from patients during the training. Patients will also be asked to practically measure blood pressure and pulse rate, adjust the prescribed medication dosage, and monitor signs and symptoms. Finally, the researchers will correct their weaknesses. In the intervention group, 60 days after the patients are discharged, a review of the previous training will be held, and the researchers will answer the patients' questions. Then, depending on the patient's needs, the patient's or family's questions will be answered, and positive feedback will be given on their strengths. Intervention 2: Control group: The control group will receive only routine care; No post-discharge education will be provided in 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 Mostafa Roshanzadeh
Borujen Faculty of Medical Sciences, Shahid Banaei Boulevard, Shahid Beheshti Square, Borujen
Borujen Iran (Islamic Republic of) 8815713471 +98 38 3423 5271 mroshanzadeh62@gmail.com Shahre-kord University of Medical Sciences scientific Farshad Heidari Beni
Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Rahmatiye, Shahrekord
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3334 1219 Heidarifarshad70@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Consent to participate in study Confirmed medical diagnosis of heart failure Ability to speak or write Ability to speak in Persian Age: 18-60 Having a mobile or landline phone Ejection fraction <55% according to the result of the echocardiography report 18 years 60 years Both Physical disability Psycho-cognitive illness Participate in similar training sessions Decreased level of consciousness I50 Heart failure Behavior Behavior Intervention group: After completing the questionnaires and reviewing their information, educational sessions will be held for a total of 60 minutes (in 3 consecutive daily sessions). The first session will be conducted face-to-face, with the patient's family member present, and the researchers will answer their questions. In the first session, only the contents of the general information booklet will be reviewed. In the next two sessions, which will be held virtually, in addition to reviewing the most important previous materials, a personalized pamphlet, tailored to each individual, will be reviewed with the patient. All developed educational materials will be derived from each patient's questionnaires, including adhering to recommended diet based on the patient's weight, regulation of activities (depending on age, gender, occupation, ejection fraction of the heart and stage of the disease), adherence to the medication regime and familiarisation with side effects, control of smoking based on individual habits, recognition of disease symptoms and adherence to training. If the patient is discharged during this period, the training will be conducted virtually by the researchers. To ensure that patients understand the material, all patients will receive an educational pamphlet, and researchers will receive regular feedback from patients during the training. Patients will also be asked to practically measure blood pressure and pulse rate, adjust the prescribed medication dosage, and monitor signs and symptoms. Finally, the researchers will correct their weaknesses. In the intervention group, 60 days after the patients are discharged, a review of the previous training will be held, and the researchers will answer the patients' questions. Then, depending on the patient's needs, the patient's or family's questions will be answered, and positive feedback will be given on their strengths. Control group: The control group will receive only routine care; No post-discharge education will be provided in this group. Self-care. Timepoint: Before, immediately and 3 months after intervention. Method of measurement: Self-Care of Heart Failure Index. Readmission risk. Timepoint: 3 months after intervention. Method of measurement: Readmission risk questionnaire. Readmission. Timepoint: 3 months after intervention. Method of measurement: Asking from patient. Shahre-kord University of Medical Sciences Approved 2025-05-20 Ethics committee of Shahrekord University of Medical Sciences Shahrekord University of Medical Sciences Headquarters, Ayatollah Kashani Blvd Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)