Effect of Training and Follow-Up through Virtual Space on Health Literacy and Resilience of Family Caregivers of Children Undergoing Hemodialysis
Design
This Semi-Experimental Study with Two Control and Intervention Groups is Conducted in Parallel and without Blinding, Non-Randomly on 60 Family Caregivers of Children Undergoing Hemodialysis.
Settings and conduct
The Location of the study is in The Hemodialysis Department of Dr. Sheikh Children's Hospital in Mashhad. The Research community includes Family Caregivers of Children with Chronic Kidney Disease who are Undergoing Hemodialysis. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria include a caregiver who is involved in patient care for at least 4 hours a day and the child receiving hemodialysis support treatment for at least 3 months. Exclusion criteria include unwillingness to participate in the study and death of the child.
Intervention groups
In the intervention group, people will receive messages in the form of text, images and audio files 3 times a week as educational and motivational messages for 3 weeks. Also, every week, a 30-minute session with the presence of 30 people. Caregivers will be held online, in which the research units will share their obstacles, problems and experiences with each other in a group discussion. In the control group, people will be trained based on the department's routine training. Questionnaires will be completed by people before the intervention, immediately after the intervention and one month after the intervention.
Main outcome variables
Health Literacy; Resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240914063036N1
Registration date:2024-10-11, 1403/07/20
Registration timing:registered_while_recruiting
Last update:2024-10-11, 1403/07/20
Update count:0
Registration date
2024-10-11, 1403/07/20
Registrant information
Name
Fariba Abaj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3892 8667
Email address
abajf4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-11, 1403/07/20
Expected recruitment end date
2025-01-09, 1403/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Training and Follow-Up through Virtual Space on Health Literacy and Resilience of Family Caregivers of Children Undergoing Hemodialysis
Public title
The Effect of Education and Follow-Up through Virtual Space on Health Literacy and Resilience
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Reading and writing literacy
Having a mobile phone
Age between 18 and 65 years
Having written informed consent
A caregiver who is involved in patient care for at least 4 hours a day and spends the most time with the patient (according to the patient's comments)
Not having medical jobs and medical education
Not having mental illnesses or anxiety disorders in the family caregiver
Not having mental illnesses or anxiety disorders in the family caregiver
A child receiving supportive hemodialysis treatment for at least 3 months
Exclusion criteria:
Unwillingness to participate in further study
Failure to complete the questionnaires correctly
Aggravation of the child's illness or hospitalization in the ICU
Death of a child
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:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the subjects that are supposed to be taught to the participants in the intervention group, according to the educational needs assessment conducted in the center and the preparation of the written educational program and the determination of standard educational priorities and educational contents approved by the center's pediatric nephrology professors, nursing education specialists and the patient education unit, as well as the fact that the researcher has been the center's patient education liaison for 6 years, and according to the weekly routine of one session, patients use the educational content based on the written program by the educator (researcher), will be collected.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Nursing and Midwifery - Mashhad University of Medical Sciences
Street address
Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2024-07-02, 1403/04/12
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.055
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Health Literacy
Timepoint
The measurement of health literacy will be done at the beginning of the study (before the start of the intervention), 3 weeks after the start of the intervention and one month after the end of the intervention.
Method of measurement
Health Literacy for Iranian Adults
2
Description
Resilience
Timepoint
Resilience will be measured at the beginning of the study (before the start of the intervention), 3 weeks after the start of the intervention and one month after the end of the intervention.
Method of measurement
Conner and Davidson Resilience Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Three online sessions and nine educational-motivational messages will be sent to the participants. In this way, based on the content needs assessment prepared for the intervention group, 3 messages in the form of text, images and audio files are shared as educational and motivational messages in the group formed in one of the internal messenger software. A 30-minute meeting will be held online with the presence of 30 family caregivers of children, in which the research units will share their obstacles, problems and experiences with each other in a group discussion. The researcher acts as a facilitator and guide and will guide the discussions based on predetermined goals. The follow-up process through cyberspace will take three weeks.
Category
Behavior
2
Description
Control group: In this group, relevant trainings that are routinely provided to patients will be given.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis Department - Dr. Sheikh Children's Hospital
Full name of responsible person
Masoud Zare
Street address
Dr. Sheikh Children's Hospital, Dr. Sheikh Ave, Tohid Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3726 9021
Email
Sheikh.hos@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research and Technology Vice-Chancellor of Mashhad University of Medical Sciences, Second Floor, Qureshi Building, Front of 16 University Ave, University Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Masoud Zare
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Kharazmi Educational Complex, University Campus, , East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ZareMD@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fariba Abaj
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Kharazmi Educational Complex, University Campus, , East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
AbajF4001@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fariba Abaj
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Kharazmi Educational Complex, University Campus, , East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
AbajF4001@mums.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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All the data obtained from this research will be shared after completion.
When the data will become available and for how long
Access to the data will be possible 3 months after the results are published.
To whom data/document is available
These data will be used for researchers working in academic and scientific institutions, as well as for people with chronic kidney failure and their caregivers.
Under which criteria data/document could be used
The data obtained from this research can be used in other scientific studies.
From where data/document is obtainable
Copying (in any way) either from the full text or from the extracts is possible only with the coordination of the supervisor and the registered author and according to the instructions provided by the central library of Mashhad University of Medical Sciences. Details are available through the relevant faculty library. Reproduction of more copies in any form of existing copies based on this recipe is not possible without the written permission of the author. In case of any previous agreement contrary to this ownership with a third party, the possibility of use without the written permission of the university, which determines the terms of such agreement, is not allowed. The use of the thesis in articles or any scientific writing is subject to citing the source in compliance with the Mashhad University of Medical Sciences publishing regulations.
Fariba Abaj:
AbajF4001@mums.ac.ir
Masoud Zare:
ZareMD@mums.ac.ir
What processes are involved for a request to access data/document
The applicant should send an email to the responsible author and register his request. After verifying the accuracy of the information of the mentioned person, the required content will be provided to him with the reference of the source.