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IRCT20150919024080N13 IRCT 2019-06-24 Khoram-Abad University of Medical Sciences The effect of multidisciplinary management on the symptom burden and medication adherence in patients with heart failure The effect of multidisciplinary management on the symptom burden and medication adherence in patients with comorbid conditions associated with heart failure 2019-01-15 anticipated 100 Complete https://irct.ir/trial/36717 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting patients with inclusion criteria and obtaining informed consent from them to participate in the study, they will be assigned to the study groups using a stratified random blocks method. layers will be considered in order to match the two groups according to sex, the class of cardiac failure and the patients' NIHA, and patients inside the layers will be assigned to the groups using random blocks of 2, 4 or 6. The random sequence list is extracted by the Statistician from the https://www.sealedenvelope.com and will be available to the researcher after identifying the above items (blocks and layers) with special codes (in order to allocation concealment). N/A Heart failure. Intervention 1: Intervention group: individuals in this group, on the day of discharge, will be visited by the cardiologist of the multidisciplinary management team and will receive medical and educational orders. The pharmacist of the team will check the medications for the interactions and side effects of the drugs and will provide the patient with the necessary recommendations. The nutritionist will evaluate the patient's body mass index and will give him ̸ her nutritional advice on the patient's needs. Finally, the nurse will prepare the patient according to the booklet, which will be delivered to the patient, and the questionnaires will be completed and the telephone follow-up and team visits will be coordinated by him ̸ her. This group will be followed by telephone at the first, fourth, and eighth weeks after discharge and on the second and sixth week after discharge, will be visited at the clinic and will complete the drug adherence questionnaire at three points (discharge, 6th week and 8th week). Intervention 2: Control group: individuals in this group would not receive any intervention from the researcher and they only will complete the research questionnaires at three points (discharge, 6th week and 8th week). Yes - There is a plan to make this available What will be shared: The total potential data will be published after unidentifying individuals in the form of information about the main outcomes. When: Access period will start since 2020 To whom: All researchers, teachers, and medical students can receive the published article from the relevant journal Conditions: Undisclosed data will be available to health science researchers for meta-analysis. Where to obtain: Send email to Parvin ghobadi@yahoo.com How to obtain: After submitting the document by applicant researcher through email, the data will be sent two weeks later. Comments:
public Mohammad Gholami
Ground floor, Negarestan 20 Alley, Shahrdari St., Velayat Blvd
Khorramabad Iran (Islamic Republic of) 6817979663 +98 66 3322 9851 Gholami.m@lums.ac.ir Khoram-Abad University of Medical Sciences scientific Dr Mohammad Gholami
Ground floor, 20th Negarestan Alley, Shahrdari St., Provincial Boulevard
Khorramabad Iran (Islamic Republic of) 6817676663 +98 66 3322 9851 Gholami.m@lums.ac.ir Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Having class of 2 to 4 Heart failure Having at least two cardiac or non-cardiac diseases Taking more than 3 drugs 30 years 80 years Both Unwillingness to participate in the study No previous history of participating in similar programs Psychiatric diagnosis requiring active treatment I50.4 Combined systolic (congestive) and diastolic (congestive) heart failure Behavior Behavior Intervention group: individuals in this group, on the day of discharge, will be visited by the cardiologist of the multidisciplinary management team and will receive medical and educational orders. The pharmacist of the team will check the medications for the interactions and side effects of the drugs and will provide the patient with the necessary recommendations. The nutritionist will evaluate the patient's body mass index and will give him ̸ her nutritional advice on the patient's needs. Finally, the nurse will prepare the patient according to the booklet, which will be delivered to the patient, and the questionnaires will be completed and the telephone follow-up and team visits will be coordinated by him ̸ her. This group will be followed by telephone at the first, fourth, and eighth weeks after discharge and on the second and sixth week after discharge, will be visited at the clinic and will complete the drug adherence questionnaire at three points (discharge, 6th week and 8th week). Control group: individuals in this group would not receive any intervention from the researcher and they only will complete the research questionnaires at three points (discharge, 6th week and 8th week). Medication adherence score in Morisky ’s questionnaire. Timepoint: During discharge, sixth, and eighth weeks after discharge. Method of measurement: Morisky ’s questionnaire. Symptom burden score in Edmonton’s questionnaire. Timepoint: During discharge, sixth, and eighth weeks after discharge. Method of measurement: Edmonton’s questionnaire. Khoram-Abad University of Medical Sciences Approved 2019-01-11 Ethics committee of Lorestan University of Medical Sciences Vice chancellor for research and technology, Lorestan University of Medical Sciences, Pardis Campus, Khorramabad-Boroujerd Road, Khorramabad, Lorestan Khorramabad Lorestan Iran (Islamic Republic of)