Investigating the effect of virtual social network interaction of family caregivers of Alzheimer's patients on their depression, anxiety and stress
Design
An experimental study of a randomized clinical trial type with a control group and two stages of pre-test and post-test, on 80 caregivers of Alzheimer's patients.
Settings and conduct
Refer to the office of internal neurologists, extract the contact number and identity of Alzheimer's patients with medical records or present in the research environment and check in terms of the desired characteristics, select qualified people, randomly divide into two control and test groups.
Participants/Inclusion and exclusion criteria
Entry requirements:
Willingness to participate in the study.
Family relationship between caregiver and patient.
Farsi language.
At least one month of continuous care.
Age above 18 years.
Care load score22with Zarit tool.
No cognitive impairment.
Not taking psychotropic drugs.
Having at least reading and writing literacy.
Internet and smartphone access.
Willingness and possibility to use the virtual messenger program.
Non-entry conditions:
Experience of participating in face-to-face or virtual programs regarding the challenges of caregivers and how to care for a patient with Alzheimer's.
The existence of a severe crisis.
Severe illness.
Intervention groups
The meaning of virtual interaction is the membership of home caregivers of the elderly with Alzheimer's disease in the intervention group and active participation in discussions and interaction with other caregivers in the group formed in the desired virtual messenger.
Main outcome variables
Mental health; Depression; Anxiety; Stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221123056586N1
Registration date:2022-12-07, 1401/09/16
Registration timing:registered_while_recruiting
Last update:2022-12-07, 1401/09/16
Update count:0
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
mohammad beyki sarvolia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 6854
Email address
m.beykisarvolia@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2022-12-08, 1401/09/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of virtual social network interaction of family caregivers of Alzheimer's patients on their depression, anxiety and stress
Public title
Investigating the impact of virtual reality on health and anxiety and care of Alzheimer's patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
The caregiver has a family relationship with a patient with Alzheimer's
Age above 18 years
At least one month of continuous care for a patient with Alzheimer's disease
Care burden score of at least 22 with Zarit tool
Not suffering from cognitive impairment
Caregiver not taking psychoactive drugs
Having at least reading and writing literacy
Internet and smartphone access
Willingness and possibility to use the virtual messenger program
Farsi language
Exclusion criteria:
Experience of participating in face-to-face or virtual programs regarding the challenges of caregivers and how to care for a patient with Alzheimer's
Existence of severe crisis such as death of loved ones or divorce in the last month
Caregiver's severe illness
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
After sampling, a number between 1 and 80 is assigned to each of the samples, then using the random site, the numbers are randomly divided between two groups, and as a result, the samples are divided into two control and test groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study in question has two control and test groups, no intervention is performed on the control group and only one type of intervention is performed on the test group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research/Ethics committees of Shahid Sadoughi University of Medical Sciences
Street address
Yazd, Shahid Qandi St., Sefir Omid Square, Jam Jam St., Noor Tower, Unit B82
City
Yazd
Province
Yazd
Postal code
8949193118
Approval date
2022-11-16, 1401/08/25
Ethics committee reference number
IR.SSU.REC.1401.061
Health conditions studied
1
Description of health condition studied
Alzheimer's disease
ICD-10 code
G30.1
ICD-10 code description
Alzheimer's disease with late onset
2
Description of health condition studied
Dementia
ICD-10 code
F03
ICD-10 code description
Unspecified dementia
3
Description of health condition studied
Aged, Elder
ICD-10 code
R54
ICD-10 code description
Age-related physical debility
4
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
5
Description of health condition studied
Stress
ICD-10 code
Z73.3
ICD-10 code description
Stress, not elsewhere classified
6
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Depression score in the 42-question depression, anxiety and stress questionnaire
Timepoint
Measuring the level of depression before the intervention and one month after the intervention
Method of measurement
42-question depression, anxiety and stress questionnaire
2
Description
Anxiety score in the 42-question depression, anxiety and stress questionnaire
Timepoint
Measuring the level of anxiety before the intervention and one month after the intervention
Method of measurement
42-question depression, anxiety and stress questionnaire
3
Description
Stress score in the 42-question depression, anxiety and stress questionnaire
Timepoint
Measuring the level of stress before the intervention and one month after the intervention
Method of measurement
42-question depression, anxiety and stress questionnaire
Secondary outcomes
1
Description
Care burden score
Timepoint
Care burden score before intervention
Method of measurement
Zarit Care Burden Questionnaire
Intervention groups
1
Description
Intervention group: creating a group in the virtual messenger for the discussion of the users of this group in such a way that the identity of each person remains anonymous to other people. designing a one-month program after the initial needs assessment in the first meetings to communicate and present to the samples of the participants in this group; Discussions in the group are in accordance with the daily designed topics. The role of researchers is to facilitate and guide group discussions. In this group, the representative and the secretary of Alzheimer's Association of Iran in Yazd will also be members to participate in group discussions.
Category
Behavior
2
Description
Control group: No intervention is performed on this group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sadra doctors building
Full name of responsible person
Dr. Kausar Pourkothari
Street address
second floor ,Sadra Doctors Building, Hana Alley, Taleghani Boulevard
City
yazd
Province
Yazd
Postal code
9867347639
Phone
+98 35 3627 5109
Email
md_kosary@yahoo.com
2
Recruitment center
Name of recruitment center
Nilofar building
Full name of responsible person
Dr. Abulqasem Rahimdel Meibodi
Street address
Second floor, Nilofar Building, The beginning of Montazer Ghaem Blvd, Mahdieh Crossroads
City
Yazd
Province
Yazd
Postal code
9857408727
Phone
+98 35 3524 3905
Email
rahimdel30142@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Alireza Moradi
Street address
Department of Medicinal Chemistry, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences
City
yazd
Province
Yazd
Postal code
9837894768
Phone
+98 35 3820 3419
Email
alirezampr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Beyki sarvolia
Position
Master's student, nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Qandi St., Safir Omid Square, Jam-e Jam St., Noor Tower, Unit B82
City
Yazd
Province
Yazd
Postal code
8949193118
Phone
+98 35 3822 6854
Fax
Email
m.beykisarvolia@stu.ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Beyki sarvolia
Position
Master's student, nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Qandi St., Safir Omid Square, Jam-e Jam St., Noor Tower, Unit B82
City
Yazd
Province
Yazd
Postal code
8949193118
Phone
+98 35 3822 6854
Fax
Email
m.beykisarvolia@stu.ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Beyki sarvolia
Position
Master's student, nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Qandi St., Safir Omid Square, Jam-e Jam St., Noor Tower, Unit B82
City
Yazd
Province
Yazd
Postal code
8949193118
Phone
+98 35 3822 6854
Fax
Email
m.beykisarvolia@stu.ssu.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
Yes - There is a plan to make this available
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
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data will only be available to researchers working in academic and scientific institutions and will be sent to individuals via email.
From where data/document is obtainable
m.beyki71@gmail .com
What processes are involved for a request to access data/document
Apply via email, then introduce yourself and the reason for this request