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IRCT20190225042843N1 IRCT 2023-01-31 Shiraz University of Medical Sciences The Effect of Home-based care Educational Program on the Severity of Delirium and Functional Status of the Elderly and the Burden of Care and Quality of Life of The informal Caregivers. The Effect of Home-based care Educational Program on the Severity of Delirium and Functional Status of the Elderly Discharged from Imam Reza Hospital in Mashhad and the Burden of Care and Quality of Life of The informal Caregivers. 2023-01-20 anticipated 60 Complete https://irct.ir/trial/67352 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: participants will assign to two intervention and control groups by the permuted block randomization (block size 4) using NCSS PASS software.By default, the software defines letters for the control and intervention groups, the user can, for example, define the letter A for the control group and the letter B for the intervention group. Finally, the output of the software is in the form of a list of 60 letters A and B which will be arranged randomly. The people under the study will be placed in one of the two groups according to the order of the diagnosis and entering the study. N/A delirium. Intervention 1: Intervention group: After completing the questionnaires, the intervention group will receive the educational program for two months.The educational content in this study will be in the form of an educational booklet containing information about delirium, its diagnostic and behavioral characteristics, and methods of controlling and dealing with delirium patients during the care of these patients.This educational booklet will be provided to the caregivers at the beginning of the program and when the intervention group patients are discharged.In addition, with the formation of a virtual group, educational materials and short films in the field of common problems of delirium patients (such as sleep problems, hallucinations and delusions, confusion and aggression, disorientation, personality and behavior problems, etc.) The written educational content has been prepared and will be gradually provided to the study participants. In addition, in order to individualize the educational program, individual consultations will be provided to the caregivers based on the problems expressed by themselves, in the context of virtual space. Intervention 2: Control group:During the intervention, the control group as well will receive the usual interventions of the health system. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD willbe shared When: for six month from october 2023 To whom: only available for people working in academic institutions Conditions: Any analysis will be allowed, but it is not allowed to publish it without mentioning the source Where to obtain: request data via email adress karimeim@sums.ac.ir How to obtain: The data will be sent within two weeks after the request Comments:
public Masoud Karimi
Razi Blvd., in front of Bargh Club, Faculty of Health
Shiraz Iran (Islamic Republic of) 71536-75541 +98 71 3725 1001 karimeim@sums.ac.ir Shiraz University of Medical Sciences scientific Masoud Karimi
Razi Blvd., in front of Bargh Club, College of Health
Shiraz Iran (Islamic Republic of) 71536-75541 +98 71 3725 1001 karimeim@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age 60 to 80 years for the patient (male and female) The elderly suffer from delirium (according to the 4AT screening test) One of the family members, as the main caregiver of the person, should take the main responsibility of taking care of the patient. The willingness of the elderly informal caregiver to participate in the study and sign the informed consent form The elderly caregiver should have at least reading and writing skills and have a smart mobile phone to communicate and receive educational messages. Be a resident of Mashhad city 60 years 80 years Both The elderly do not suffer from obesity, physical disabilities, and chronic diseases that usually prevent them from performing daily tasks, before being admitted to the hospital. Z74.2 Other problems related to care-provider dependency Treatment - Other Treatment - Other Intervention group: After completing the questionnaires, the intervention group will receive the educational program for two months.The educational content in this study will be in the form of an educational booklet containing information about delirium, its diagnostic and behavioral characteristics, and methods of controlling and dealing with delirium patients during the care of these patients.This educational booklet will be provided to the caregivers at the beginning of the program and when the intervention group patients are discharged.In addition, with the formation of a virtual group, educational materials and short films in the field of common problems of delirium patients (such as sleep problems, hallucinations and delusions, confusion and aggression, disorientation, personality and behavior problems, etc.) The written educational content has been prepared and will be gradually provided to the study participants. In addition, in order to individualize the educational program, individual consultations will be provided to the caregivers based on the problems expressed by themselves, in the context of virtual space. Control group:During the intervention, the control group as well will receive the usual interventions of the health system. Severity of delirium. Timepoint: before the start of the intervention and after the completion of the intervention. Method of measurement: Questionnaire Delirium Rating Scale-revised-98 (DRS-R-98). Performance in terms of activities of daily living. Timepoint: before the start of the intervention and after the completion of the intervention. Method of measurement: Questionnaire activities of daily living (ADL). Performance in terms of instrumental activities of daily living. Timepoint: before the start of the intervention and after the completion of the intervention. Method of measurement: Questionnaire of instrumental activities of daily life (IADL). Caring load in caregivers based on the Zarit questionnaire. Timepoint: After the intervention. Method of measurement: Zarit questionnaire. Quality of life based on SF-12 questionnaire. Timepoint: before the start of the intervention and after the completion of the intervention. Method of measurement: Short Form Health Survey - 12 Item. Shiraz University of Medical Sciences Approved 2022-04-17 Ethics Committee of Shiraz University of Medical Sciences Zand St., central building of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)