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IRCT20230829059300N1 IRCT 2023-09-18 Tehran University of Medical Sciences Effect of of follow-up care on self management for heart failure patients Effect of implementation of follow-up care model on self-management in patient with chronic heart failure disease 2022-12-01 anticipated 70 Complete https://irct.ir/trial/72338 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After determining the sample size, the patients were assigned into blocks each block containing the same number of participants. Blocks were then randomly chosen to determine the patients’ assignment into the control and study groups. N/A Heart failure ( can be attributed to various cardiovascular diseases, however, it consistently leads to the same cardiac irregularities, regardless of whether they affect the heart's contractile capacity (systole), filling capacity (diastole), or both.. Intervention 1: Intervention group: The patients in the intervention group received an educational booklet based on heart failure self-management. The intervention consisted of providing two training sessions, each of which was scheduled to last one hour and take place at a training facility located within Al-Imam AL-Hussain Medical City in Karbala. Sessions cover topics such as understanding the disease's progression, the importance of medication and getting to know the drugs, the best way to take them, and any potential side effects, as well as managing the disease through changes in diet, fluid intake, daily weight, exercise, and symptom management. Patients in the research group were contacted by phone and sent weekly messages for a period of three months for the purpose of following up with them. The number of contacts that were made with the patient was sufficient to allow for the establishment of weekly communication with each patient. The duration of each patient's phone call varied based on their individual circumstances and the number of questions they had about their condition. Twelve contacts were established with each patient over the course of three months. Additionally, each patient received 24 messages over the course of 12 weeks, divided between two messages per week. Patients and their fellows were provided a written outline of the training sessions' contact schedule during the study. Finally, the success of the intervention was evaluated by using the SCHFI questionnaire for measuring and comparing self-management. One, two, and three months after the intervention, a questionnaire was completed for both groups. Intervention 2: Control group: The patients in the control group received the usual care at Al-Imam Al-Hussain Medical City but at the end of the intervention, they had access to the educational material. Yes - There is a plan to make this available What will be shared: in IPD the Demographic information including age, gender, marital status, level of education, stage of heart failure, duration of heart disease, side of heart failure, number of hospitalizations during the last three months, and occupation Status will be shared. When: when the research is published and won't be removed To whom: researcher and the health care provider Conditions: the data will be available for all researchers and the health care provider without any criteria Where to obtain: contact with this Email: ac_milan515@yahoo.com How to obtain: data will sent to the applicant after receiving his request Comments:
public Alireza Nikbakht Nasrabadi
Nosrat st. Tohid sq. Tehran I.IRAN
Tehran Iran (Islamic Republic of) 1416634793 +98 912 205 5362 nikbakht@tums.ac.ir Tehran University of Medical Sciences scientific Shokoh Varaei
Nosrat st. Tohid sq. Tehran I.IRAN
Tehran Iran (Islamic Republic of) 1416634793 +98 912 218 6498 shvaraei@sina.tums.ac.ir Tehran University of Medical Sciences Iraq Patients who were diagnosed with heart failure since 6 month and more Patients who were accepted to attended in study Patients who were conscious Patients with stage three and four heart failure. no limit no limit Both Patients who were reluctant to attended in the study. Patients without mental disorders I50 Heart failure Other Other Intervention group: The patients in the intervention group received an educational booklet based on heart failure self-management. The intervention consisted of providing two training sessions, each of which was scheduled to last one hour and take place at a training facility located within Al-Imam AL-Hussain Medical City in Karbala. Sessions cover topics such as understanding the disease's progression, the importance of medication and getting to know the drugs, the best way to take them, and any potential side effects, as well as managing the disease through changes in diet, fluid intake, daily weight, exercise, and symptom management. Patients in the research group were contacted by phone and sent weekly messages for a period of three months for the purpose of following up with them. The number of contacts that were made with the patient was sufficient to allow for the establishment of weekly communication with each patient. The duration of each patient's phone call varied based on their individual circumstances and the number of questions they had about their condition. Twelve contacts were established with each patient over the course of three months. Additionally, each patient received 24 messages over the course of 12 weeks, divided between two messages per week. Patients and their fellows were provided a written outline of the training sessions' contact schedule during the study. Finally, the success of the intervention was evaluated by using the SCHFI questionnaire for measuring and comparing self-management. One, two, and three months after the intervention, a questionnaire was completed for both groups. Control group: The patients in the control group received the usual care at Al-Imam Al-Hussain Medical City but at the end of the intervention, they had access to the educational material. Self-management: is the control and responsibility that an individual takes on for the management of their conditions and behaviors. Timepoint: before the intervention and one, two three month after the intervention. Method of measurement: the self management measured by the selfcare of heart failure index version 7.2 scale. Number of re-hospitalizations in last three months for the heart failure patients. Timepoint: before the intervention and after three month. Method of measurement: the demographic questionnaire. Tehran University of Medical Sciences Approved 2022-10-25 Research ethical committees of school of nursing and midwifery and rehabilitation - TUMS Nosrat st. Tohid sq. Tehran Tehran Tehran Iran (Islamic Republic of)