The effect of family-centered empowerment model on family function and care burden of primary caregivers of children with glucose-6-phosphate dehydrogenase enzyme deficiency
Determining the effect of family-centered empowerment model on family function and care burden of the main caretaker of children with glucose-6-phosphate dehydrogenase enzyme deficiency
Design
The clinical trial has two groups of control and intervention, with parallel groups, without blindness, simple randomization, in which 30 individuals will be included in the study. At first, children with favism admitted to the Iranian hospital were randomly selected based on the purpose of the selected patients and classified according to age group in three floors (6 to 8 years) - (9 to 11 years) - (12 to 14 years) In each step, patients will be randomly assigned to intervention and control groups. In this way, pre-made white cards will be randomly assigned to each patient, and a color card is written that the green color represents the intervention group and the blue color representing the control group.
Settings and conduct
Population under study: The population of the study consisted of the main carers of children aged 6 years and older who lacked the glucose-6-phosphate dehydrogenase enzyme present at or admitted to the Iran Iran Hospital
Environment and Research Time: Iran Hospital, Iranshahr City, Bahar 1398
Participants/Inclusion and exclusion criteria
Having a child with glucose-6-phosphate dehydrogenase deficiency ages 6 to 14 years
Having reading and writing skills and the ability to complete a questionnaire in the main caregiver
There is no history of formal education about favic disease before studying
The ability to speak and listen in the main caregiver
Having the right to decide on the prevention and treatment of childhood illness
Intervention groups
The implementation of the family-centered empowerment model on the intervention group consists of 4 steps in 5 sessions of 90 minutes
Main outcome variables
care burden
Family function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043936N1
Registration date:2019-07-18, 1398/04/27
Registration timing:prospective
Last update:2019-07-18, 1398/04/27
Update count:0
Registration date
2019-07-18, 1398/04/27
Registrant information
Name
Saeed Kalkali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 7253 2085
Email address
saeedkalkali@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment model on family function and care burden of primary caregivers of children with glucose-6-phosphate dehydrogenase enzyme deficiency
Public title
The effect of family-centered empowerment model on family function and care burden of primary caregivers of children with favism
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Completion of written consent form to participate in the study
Having a child with glucose-6-phosphate dehydrogenase deficiency ages 6 to 14 years
Literacy and ability to complete the questionnaire in the main caregiver
The main caregiver is not a member of the medical and nursing group
Lack of chronic disease in other family members
There is no history of formal education about favic disease before the study
The ability to speak and listen to the patient and the main caregiver
Being responsible for the maximum daily care of the child
Having the right to decide on the prevention and treatment of childhood illness
Exclusion criteria:
Not willing to continue participating in the scheme
Absence for any reason two consecutive sessions that can not attend meetings
Not available for communicating and informing sessions
To create a special event affecting the quality of life and the specific mental illness in the main caregiver
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
60
The main guardian and the child
Randomization (investigator's opinion)
Randomized
Randomization description
Preset White Cards will be randomly assigned to each patient and will be written on a color card representing the color of the intervention group and the blue color of the control group.
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
Birjand University of Medical Sciences
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.BUMS.REC.1398.107
Health conditions studied
1
Description of health condition studied
Glocos 6 phospat dehydrogenaz enzim definenshe
ICD-10 code
D55.0
ICD-10 code description
Anaemia due to glucose-6-phosphate dehydrogenase [G6PD] deficiency
Primary outcomes
1
Description
Care load score in Zarit questionnaire
Timepoint
Before the intervention and a month later
Method of measurement
caring-burden-inventory-CBI-Zarit
2
Description
McMaster family functioning score in the questionnaire.
Timepoint
Before the intervention and a month later
Method of measurement
Family Assessment Device (FAD) McMaster
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Family-based empowerment model was implemented based on four perceived threat, self-efficacy, educational participation and evaluation.
Category
Lifestyle
2
Description
Control group: Routine care and a training session
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran hospital
Full name of responsible person
saeed kalkali
Street address
Shahid Moradi Highway, 3 km from Iranshahr, Bampour Road
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9941114496
Phone
+98 54 3721 2460
Fax
+98 54 3721 0483
Email
Irshums@irshums.ac.ir
Web page address
http://iranhospital.irshums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Miri Moghadam
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
public_r@bums.ac.ir
Web page address
https://www.bums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
saeed kalkali
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghaffari street, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1400
Fax
+98 56 3163 1400
Email
saeedkalkali@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ali Mohammad Izad Panah
Position
Master of Science (MSc) Nursing and Scientific Staff
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghaffari Steet, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1400
Email
izadpanahy@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Saeed kalkali
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
خیابان غفاری - دانشگاه علوم پزشکی بیرجند
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 32381400056
Email
saeedkalkali@bums.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
Not applicable
Title and more details about the data/document
All individual data can be shared with researchers and the medical team after unidentifiable individuals.
The method and outcome of the work in the form of an article can be shared for all researchers and the medical and medical team
When the data will become available and for how long
After completing the work and obtaining the result
To whom data/document is available
Researchers, medical team, medical education team, students
Under which criteria data/document could be used
For use in other research
From where data/document is obtainable
Library of Birjand University of Medical Sciences
What processes are involved for a request to access data/document
Referring to the library of Birjand University of Medical Sciences and using it or sending an e-mail to scientific research officer Mr. Ali Mohammad Izadpanah