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.
the impact of the delirium home care education on the severity of delirium and the functional status of the elderly after being discharged from Imam Reza Hospital in Mashhad and the burden of care and the quality of life of their caregivers.
Design
Randomized controlled educational experiment, 60 elderly people with delirium will be assigned to the intervention and control groups using permutation blocks. 30 people in each group.
Settings and conduct
the study will be conducted in Imam Reza Mashhad Hospital. the patients who meet the inclusion criteria will enter the study . People are divided into two intervention and control groups using permuted blocks randomization.The questionnaires will completed by the elderly caregivers and the intervention group receives the educational contens for 2 months.Then the questionnaires are completed in both groups two months after the intervention.
Participants/Inclusion and exclusion criteria
The severity of delirium in the elderly is moderate or higher based on the DRS-98 questionnaire (score higher than 13.5); Not taking psychoactive drugs (such as opiates, antihistamines, etc.).
Intervention groups
An educational booklet containing information about delirium disease will be available to their caregivers when the patients in the intervention group are discharged. with the formation of the virtual group, educational materials and short films in the fields of common problems patients will be gradually provided to the participants.Individual consultations will also be provided to the caregivers based on the problems expressed by themselves, in the context of virtual space.During this period, the control group will receive the usual interventions in the health system.
Main outcome variables
Delirium; caregivers' burden.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190225042843N1
Registration date:2023-01-31, 1401/11/11
Registration timing:registered_while_recruiting
Last update:2023-01-31, 1401/11/11
Update count:0
Registration date
2023-01-31, 1401/11/11
Registrant information
Name
Masoud Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1001
Email address
karimeim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
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.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand St., central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2022-04-17, 1401/01/28
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1401.018
Health conditions studied
1
Description of health condition studied
delirium
ICD-10 code
Z74.2
ICD-10 code description
Other problems related to care-provider dependency
Primary outcomes
1
Description
Severity of delirium
Timepoint
before the start of the intervention and after the completion of the intervention
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)
3
Description
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)
4
Description
Caring load in caregivers based on the Zarit questionnaire
Timepoint
After the intervention
Method of measurement
Zarit questionnaire
5
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
Control group:During the intervention, the control group as well will receive the usual interventions of the health system.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Mashhad
Full name of responsible person
Masoud Karimi
Street address
Razi Blvd., in front of Bargh Club, College of Health
City
Shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Email
karimeim@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehtab Memarpour
Street address
Razi Blvd., in front of Bargh Club, Faculty of Health
City
Shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Email
karimeim@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoud Karimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical doctor, MPH
Street address
Razi Blvd., in front of Bargh Club, Faculty of Health
City
Shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Email
karimeim@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoud Karimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Doctor, MPH
Street address
Razi Blvd., in front of Bargh Club, College of Health
City
Shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Email
karimeim@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoud Karimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Razi Blvd., in front of Bargh Club, College of Health
City
Shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Email
karimeim@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
all collected deidentified IPD willbe shared
When the data will become available and for how long
for six month from october 2023
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
Any analysis will be allowed, but it is not allowed to publish it without mentioning the source
From where data/document is obtainable
request data via email adress
karimeim@sums.ac.ir
What processes are involved for a request to access data/document
The data will be sent within two weeks after the request