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IRCT20190913044760N3 IRCT 2024-02-04 Tehran University of Medical Sciences Effect of peer support on quality of life and self care in patients with cardiac implanted electronic device Effect of peer support on quality of life and self care in patients with cardiac implanted electronic device 2024-02-20 anticipated 60 Complete https://irct.ir/trial/74476 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: Paying attention to the fact that the number of samples is limited according to the entry criteria and since it is not possible to conduct a study in a multi-centered manner due to the time limit available to the researcher,Until the required sample size is reached, sampling can continue. To prevent leakage of information between the control and intervention groups, sampling will be done in the control group first, and after reaching the required sample size, sampling will be done in the intervention group. N/A Pacemekers. Intervention 1: Control group:In the Catheterization laboratory and Heart Department of Imam Khomeini hospital, as a control, patients are asked to complete the study tools after obtaining informed consent. The above process will continue until reaching the determined sample size. Intervention 2: Intervention group:In the Catheterization laboratory and Heart Department of Imam Khomeini hospital after obtaining informed consent from the patients, the study instrument is completed by them. Then peer support intervention is done for them under the supervision of the research team; In this way, the peers call the patients at least twice a week for a month and exchange information and solve the patients' problems, and the researcher calls the peers at least twice a week and inquires about the condition of the patients and answers their questions. At the end of the first month and then the second month after the intervention, the study tool is completed again by the patients. Yes - There is a plan to make this available What will be shared: All unidentifiable data can be provided if required When: Access period starts 6 months after the results are published To whom: All researchers working in academic and scientific institutions who send requests Conditions: The data can be used in accordance with copyright law and for conducting further research in this field. Where to obtain: Send an email to Ms. Hanieh Kordi Kalaki at Hanieh.kordi@gmai.com How to obtain: After reviewing the request and the conditions of the applicant, if approved, the data will be sent within one month. Comments:
public Hanieh Kordi kalaki
Gholhak St
Tehran Iran (Islamic Republic of) 1939646436 +98 21 2264 1793 Hanieh.kordi@gmail.com Tehran University of Medical Sciences scientific Zahra Abbasi Dolatabadi
Mirkhani Blvd
Tehran Iran (Islamic Republic of) 1419733171 +98 21 4329 6105 zahra_abasi2000@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) People between 18 and 60 years old People for whom implantable equipment is installed inside the heart for the first time People who speak Persian People who have access to mobile phones 18 years 60 years Both Underlying diseases include kidney failure and strokes People with known and treated cognitive disorders Having a history of replacing the generator Participation in the previous similar plan Z95.0 Presence of cardiac pacemaker Other Other Control group:In the Catheterization laboratory and Heart Department of Imam Khomeini hospital, as a control, patients are asked to complete the study tools after obtaining informed consent. The above process will continue until reaching the determined sample size. Intervention group:In the Catheterization laboratory and Heart Department of Imam Khomeini hospital after obtaining informed consent from the patients, the study instrument is completed by them. Then peer support intervention is done for them under the supervision of the research team; In this way, the peers call the patients at least twice a week for a month and exchange information and solve the patients' problems, and the researcher calls the peers at least twice a week and inquires about the condition of the patients and answers their questions. At the end of the first month and then the second month after the intervention, the study tool is completed again by the patients. Quality of life. Timepoint: Before the intervention and 1 and 2 months after the intervention. Method of measurement: Questionnaire for assessment of Quality of life and Related events of patients with electronic cardiac implantable devices. Self care. Timepoint: Before the intervention and 1 and 2 months after the intervention. Method of measurement: Miller self care questionnaire. Tehran University of Medical Sciences Approved 2023-08-29 Ethics committee of Imam Khomeini Hospital of Tehran university of medical sciences Imam Khomeini Hospital Complex, Dr. Gharib Street, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)