Investigating the effect of psychological education on the Internet on the psychological burden of caregivers of patients with moderate to severe dementia
Design
A controlled clinical trial with parallel groups, no blinding, randomized for phase 2 on 80 caregivers. The rand function of Excel software was used for randomization.
Settings and conduct
Training for caregivers of dementia patients on the Internet in the city of Kashan in the form of a video package
Participants/Inclusion and exclusion criteria
Inclusion criteria : Caregivers of patients with moderate to severe dementia
Age between 18 and 65 years
Education of 5th grade and above
Ability to work with the internet and mobile phone
Willingness to participate in the study
No nursing care experience
Care outside nursing homes and care centers
Caregiving at least 4 hours a week
Exclusion criteria : Caregivers of patients with dementia + other major psychiatric disorders
with major psychiatric disorders
with mild dementia
patients who die during the study
without the possibility of online or offline communication
unwilling to participate in any part of the study
leave more than two treatment sessions
Physical disability in the caregiver or patient
Ill-educated caregivers
provide care in nursing homes and treatment centers
Intervention groups
Caregivers of patients with moderate to severe dementia
Intervention includes educational videos on the Internet
Control group accesses the training after the end of the study
Main outcome variables
Reducing the psychological burden
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241122063796N1
Registration date:2024-12-21, 1403/10/01
Registration timing:registered_while_recruiting
Last update:2024-12-21, 1403/10/01
Update count:0
Registration date
2024-12-21, 1403/10/01
Registrant information
Name
Jalal Mirabdollah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4404 5151
Email address
mirabdollah-@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-10, 1403/09/20
Expected recruitment end date
2025-02-08, 1403/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of internet-based psychoeducation on the burden of caregivers of patients with moderate to severe dementia
Public title
The effect of internet-based psychoeducation on the burden of caregivers of patients with dementia
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Caregivers of dementia patients with a record of moderate to severe dementia and re-confirmation by a psychiatrist
Caregivers were between 18 and 65 years old at the time of participation in the study.
Education level, 5th grade and above
Ability to work with the Internet and information applications on mobile phones and home computers
Willingness to participate in research
Not trained in the basics of nursing care
Provide care in a location outside of nursing homes and care centers
Spend at least 4 hours a week caring for the elderly.
Exclusion criteria:
Caregivers of patients with dementia who have another major psychiatric disorder with a proven diagnosis or identified by interview
Caregivers of patients with dementia whose caregiver has a major psychiatric disorder proven by diagnosis or identified by interview.
Caregivers of patients with mild dementia
Caregivers of patients who die during the study
Caregivers who do not have the ability to communicate online or offline.
Caregivers who are unwilling to participate in any part of the research
Caregivers who miss more than two training sessions.
Having a physical disability in the caregiver or patient
Illiterate caregivers
Caregivers who provide care in nursing homes and treatment centers
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization unit is the individual. A simple non-probability randomization method in which, after considering the entry and exit criteria and selecting homogeneous participants, randomization is performed using a randomization tool, which is the Rand Company's random number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kashan University of Medical Sciences
Street address
Qotb Ravandi Blvd
City
kashan
Province
Isfehan
Postal code
8715973474
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.301
Health conditions studied
1
Description of health condition studied
Burden of caregivers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Burden scale caregivers
Timepoint
Measurement of psychological burden at the beginning of the study, at the end of the intervention, and three months after the end of the intervention.
Intervention group: Includes 40 caregivers of patients with moderate and severe dementia who were randomly selected. The intervention includes providing psychological educational packages in the form of videos prepared by the project manager and psychiatrist professors, on the internal messenger 'Yes' and 'Aparat site' in the form of sessions 3 times a week to caregivers of patients with moderate and severe dementia. These videos will be placed on a predetermined schedule in a special channel for this study in the messenger 'Yes' and the videos will remain on the channel until the end of the project and participants will have the opportunity to watch online or download and watch the educational packages offline. All educational packages will also be placed simultaneously on the Aparat site and it will be possible to watch them online and offline. The educational content includes 20 sessions, three times a week and for 8 weeks. The description of the content of the educational sessions is given in the table below. These sessions are conducted interactively with the caregivers, and at the end of the sessions and after watching the educational package, in addition to answering the caregivers' questions The answer is "yes" either by phone or in a special group for this research in the messenger, with questions asked by the project manager to the caregivers to ensure that they have watched the educational package. Also, a text summary before asking questions will be given to the participants after the end of each session. Again, at the end of the weekly sessions, the caregivers' questions will be answered via internal messenger, telephone or in person. If an urgent question is raised after each session or between sessions, individuals will be able to access psychiatrists and specialists from the geriatric health team by phone at specific hours.
Category
Other
2
Description
Control group: Includes 40 caregivers of patients with severe and moderate dementia who have been randomly selected. The control group will only receive the usual face-to-face training during their patient visits and will not receive any additional psychological educational intervention on the Internet. In the pre-test phase, the standard ZARIT Psychological Burden Scale questionnaire will be administered to both the intervention and control groups. This questionnaire will be presented to the caregiver in person and after an introductory session and obtaining consent to participate in the study to answer it. After completing the psychological education sessions on the Internet for the intervention group and after the end of the follow-up period, which is 3 months after the end of the intervention, the aforementioned questionnaires will be administered to both the control and intervention groups.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kargarnejad hospital
Full name of responsible person
Jalal mirabdollah
Street address
Parastar Blvd,Qotb Ravandi Blvd,Kashan,Iran
City
Kashan
Province
Isfehan
Postal code
۸۷۱۵۹۷۳۴۴۶
Phone
+98 31 5558 9211
Fax
+98 31 5588 1124
Email
Kargarnejad@kaums.ac.ir
Web page address
https://kargarnejad.kaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Gholamali hamidi
Street address
Qotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 3166
Fax
+98 31 5558 9444
Email
Int@kaums.ac.ir
Web page address
Https://en.kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
1
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
Kashan University of Medical Sciences
Full name of responsible person
Jalal Mirabdollah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Unit 9, No 28, Fadak medical complex, East etemadian st , Sadeghiyeh 2nd sq
City
Tehran
Province
Tehran
Postal code
1487763681
Phone
+98 21 4404 5151
Fax
Email
Mirabdollah-@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Jalal mirabdollah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Unit 9, No 28, Fadak medical complex, East etemadian st , Sadeghiyeh 2nd sq
City
Tehran
Province
Tehran
Postal code
1487763681
Phone
+98 21 4404 5151
Email
Mirabdollah-@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Jalal mirabdollah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Unit 9, No 28, Fadak medical complex, East etemadian st , Sadeghiyeh 2nd sq
City
Tehran
Province
Tehran
Postal code
1487763681
Phone
+98 21 4404 5151
Email
Mirabdollah-@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participant Data File (IPD) All data potentially shareable after de-identification
Study Protocol All data potentially shareable after de-identification
Statistical Analysis Plan All data potentially shareable after de-identification
Informed Consent Form All data potentially shareable after de-identification
Codes used in analysis All data potentially shareable after de-identification
Data Classification System (Data Dictionary) All data potentially shareable after de-identification
When the data will become available and for how long
Access period starts 6 months after results are published.
To whom data/document is available
Researchers working in academic and scientific institutions and people who are also involved in industry
Under which criteria data/document could be used
The use of data to improve diagnostic and therapeutic processes, and to rehabilitate and support patient caregivers is permitted.
From where data/document is obtainable
jalal.mirabdollah@gmail.com
What processes are involved for a request to access data/document
Jalal mirabdollah - jalal.mirabdollah@gmail.com
Send the application and documents via email, then check the accuracy of the information. This process will take two weeks. Then the information will be sent within a month.