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IRCT20190203042608N1 IRCT 2019-12-29 Esfahan University of Medical Sciences Investigating the Effect of Adherence to Therapeutic Regimen program on the Quality of Life in Patients with Atrial Fibrillation Investigating the Effect of Adherence to Therapeutic Regimen program on the Quality of Life in Patients with Atrial Fibrillation 2018-01-15 anticipated 50 Complete https://irct.ir/trial/42319 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: To collect data, having obtained the required permissions accompanied with the authorities’ agreement and cooperation, the researcher refers to the CCU, Post CCU, and internal cardiology units of the Chamran Hospital and extracts the list of patients with atrial fibrillation arrhythmia introduced by the cardiologist specialists in these units. Then, she talks to all patients having the inclusion criteria, and, in addition to introducing herself, she explains them the purpose of the study. Finally, the qualified samples for the study are simply selected, and, having acquired their written informed consent, we will include them in the study. The randomization is implemented as the following: the samples are given numbers from the list of random numbers, and, according to the numbers, the even ones are assigned to the experimental group and the odd ones are assigned to the control group. This task continues until the considered sample number is achieved. N/A Atrial Fibrillation. Intervention 1: A compiled therapeutic regimen program which is a synthesis of personal training and practicing in two 45-minute successive sessions. On the second and third days of hospitalization, during the hours 9 to 11, and with the aid of illustrated pictures of an educational booklet, there will be face to face discussions between the patients and the researcher on the arrhythmia type, the therapeutic method, the used drugs and their side effects, the amount of activity, how to face psychological problems, the significance of conducting coagulation tests, the type of nourishing, and a plan to correctly face probable problems. At the end of the second session, the experimental group will be given an educational booklet concerning the presented issues in adherence to a therapeutic regimen program. The telephone call happens between 8 in the morning and 8 at night on certain dates and times according to the agreement between the researcher and the patient and its content is encouraging the presented discussions in the sessions, question and answer, reinforcing the lessons, and the disease management power. Then, there will be no intervention for 8 weeks. Finally, 12 weeks after the intervention, the questionnaire will be filled out by the educational colleague. Intervention 2: Control group: This group will receive the usual cares besides a personal 30-minute session concerning the atrial fibrillation disease. One month after the intervention, a researcher colleague possessing no information on the study purposes will fill out the questionnaire via the questioning method and by the use of data included in the histories of the experimental and control groups. Yes - There is a plan to make this available What will be shared: The entire data present in the questionnaire is sharable after it becomes unidentifiable When: The accessibility onset is up to 5 years after printing the results To whom: It will be accessible to all researchers working in scientific and academic institutions Conditions: The resultant documents can be referred to in similar studies on the patients with atrial fibrillation, the effect of regimen according to demographic variables, and similar issues Where to obtain: Referring to the library of the nursing faculty and receiving the electronic file of the thesis The personal e-mail of the researcher Fatima Yazdizadeh: yazdizadeh.f71@gmail.com How to obtain: The document appliers should have valid student number from their university or ethics code from the respected university. Moreover, they should present the full specifications of their advisors while they receive the documents so that they can hold them for two weeks. Comments:
public Fatemeh Yazdizadeh
Number 5, Palestine Boulevard the 16th
Shirvan Iran (Islamic Republic of) 9461658685 +98 83 3835 8258 yazdizadeh.f71@gmail.com Esfahan University of Medical Sciences scientific Fatemeh Yazdizadeh
Number 5, Palestine Boulevard the 16th
Shirvan Iran (Islamic Republic of) 9461658685 +98 936 845 2985 yazdizadeh.f71@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 7- The Main Inclusion criteria in the Study before Randomization Those patients with atrial fibrillation arrhythmia diagnosed and treated by cardiologist specialists. Those patients with atrial fibrillation arrhythmia hospitalized for the first time. Those patients that are in the age range between 35 and 70 years old 35 years 70 years Both Patients’ disinclination to participate in the intervention Patients’ with physical and psychological problems leading to their disabilities 3. Patients below 35 years old and above 70 years old I48.1 Persistent atrial fibrillation Diagnosis Diagnosis A compiled therapeutic regimen program which is a synthesis of personal training and practicing in two 45-minute successive sessions. On the second and third days of hospitalization, during the hours 9 to 11, and with the aid of illustrated pictures of an educational booklet, there will be face to face discussions between the patients and the researcher on the arrhythmia type, the therapeutic method, the used drugs and their side effects, the amount of activity, how to face psychological problems, the significance of conducting coagulation tests, the type of nourishing, and a plan to correctly face probable problems. At the end of the second session, the experimental group will be given an educational booklet concerning the presented issues in adherence to a therapeutic regimen program. The telephone call happens between 8 in the morning and 8 at night on certain dates and times according to the agreement between the researcher and the patient and its content is encouraging the presented discussions in the sessions, question and answer, reinforcing the lessons, and the disease management power. Then, there will be no intervention for 8 weeks. Finally, 12 weeks after the intervention, the questionnaire will be filled out by the educational colleague. Control group: This group will receive the usual cares besides a personal 30-minute session concerning the atrial fibrillation disease. One month after the intervention, a researcher colleague possessing no information on the study purposes will fill out the questionnaire via the questioning method and by the use of data included in the histories of the experimental and control groups The quality-of-life in patients with atrial fibrillation in the AFEQT questionnaire. Timepoint: Investigating the quality of life at the study outset, one month and three months after the intervention. Method of measurement: The atrial fibrillation effect on the quality-of-life questionnaire. The atrial fibrillation symptoms including heartbeat, chest pain, shortness of breath, and vertigo. Timepoint: All items accomplished before the intervention, and one month and three months after the intervention. Method of measurement: All items are from the atrial fibrillation effect on the quality-of-life questionnaire for the patients with atrial fibrillation. Esfahan University of Medical Sciences Approved 2018-01-14 The Ethics Committee of Isfahan, University of Medical Sciences The Headquarters, Isfahan, University of Medical Sciences and Healthcare Services, Hezarjarib Street Isfahan Isfehan Iran (Islamic Republic of)