Comparison of quality of life of children and care burden in two groups of intervention and control.
Design
50 pairs of children with hemophilia and their main caregiver and randomly selected blocks, which consists of 6 blocks and 4 groups and divided into two groups (25 persons).
Settings and conduct
Obtaining informed consent, the quality of life questionnaire by the child, and the Zarit care burden questionnaire will be completed by the primary caregiver. In order to intervene, family-empowerment will be used. The intervention includes self-care behaviors training based on the family-centered empowerment model, which was conducted by a researcher in the conference hall during nine sessions of 60-90 minutes twice a week based on four steps in understanding the threat, problem solving, educational participation and evaluation. The hospital will be attended by primary caregivers and children with hemophilia.Face-to-face meetings with slideshows and films and pamphlets will be provided face-to-face and face-to-face meetings. The control group will receive only a routine treatment and care program, and again after the 9th week (one month after the intervention group training program) The quality of life questionnaire for Hemophilia children and the Zarit care burden questionnaire for the control group will be completed.
Participants/Inclusion and exclusion criteria
The desire to participate in the research and diagnosis of a child's illness and having a case in the hematologic clinic and not having any other chronic disease other than hemophilia.
Intervention groups
Family-based empowerment training for parents in two groups: intervention and control.
Main outcome variables
The results of this study, if positive, can be a way to improve self-care behaviors and consequently, in addition to reducing the family care burden, it can improve their quality of life.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181123041733N1
Registration date:2018-12-21, 1397/09/30
Registration timing:retrospective
Last update:2018-12-21, 1397/09/30
Update count:0
Registration date
2018-12-21, 1397/09/30
Registrant information
Name
Soulmaz Namaki KHameneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3558 8269
Email address
namakikhameneh.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-03, 1397/08/12
Expected recruitment end date
2018-12-11, 1397/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Family-Centered Empowerment on Quality of Life of Children with hemophilia and the care burden of caregivers
Public title
The effect of Family-Centered Empowerment on Quality of Life of Children with hemophilia and the care burden of caregivers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in research.
Diagnosis of a child with hemophilia by a physician and having a case at hematologic clinic of Baghaee Hospital, Ahvaz, Iran
There is no other chronic disease other than hemophilia, such as diabetes, asthma, thalassemia.
Age range 12-8 years
Exclusion criteria:
Lack of record of participation in previous training programs
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
At first, qualified individuals, including their main carers and their children, are selected according to entry criteria and then divided into two groups of 25 pairs, using randomized block random method, and randomly assigned random numbers. Then the study questionnaires will be completed for both groups. . The quality of life questionnaire will be completed by the child. The Persian version of Zarit's Care Weight Questionnaire will be completed by the primary caregiver of the child and, if necessary, by the interviewer's method, will be completed by the researcher at the Hepatitis Clinic of Baqaee Hospital 2. In order to intervene, the researcher in this study will use a family-centered empowerment model based on its comprehensive approach among all types of empowerment approaches. This template was designed by Alhani et al. In 2003 (38). It should be noted that the intervention group will be divided into 2 groups of 8 pairs and 1 pairs of 9 pairs (including the main caregiver and the affected child).
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
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Padada lands, avenue of knowledge, Complex Yazdan 5, Plot 62, Unit 2
City
Ahvaz
Province
Khouzestan
Postal code
5154550888
Approval date
2018-11-05, 1397/08/14
Ethics committee reference number
IR.AJUMS.REC.1397.571
Health conditions studied
1
Description of health condition studied
Family-centered empowerment education on the quality of life of children with hemophilia and caring burden.
ICD-10 code
D68.0
ICD-10 code description
Von Willebrand's disease
Primary outcomes
1
Description
Quality of life for children with hemophilia
Timepoint
Before the intervention and 37 days after the intervention began
Method of measurement
Hemophilia quality of life questionnaire
2
Description
Caregivers for carers of children with hemophilia
Timepoint
Before the intervention and 37 days after the intervention began
Method of measurement
Zarit's Care Bar Questionnaire
Secondary outcomes
1
Description
Improving the quality of life
Timepoint
45 days
Method of measurement
Hemophilia Quality of Life Questionnaire, Zarit's Care Weight Inventory
Intervention groups
1
Description
Intervention group: In order to intervene, the researcher in this study will use a family-centered empowerment model based on its comprehensive approach among all types of empowerment approaches. This template was designed by Alhani et al. In 2003 (38). It should be noted that the intervention group will be divided into 2 groups of 8 pairs and 1 pairs of 9 pairs (including the main caregiver and the child). The intervention will include the implementation of a self-care behaviors training program based on a family-centered empowerment model that during 9 sessions of 90- A 60-minute sessions a week, based on four steps in understanding the threat, problem solving, educational participation and evaluation, will be carried out by a researcher at the hospital conference hall with the presence of primary carers and children with hemophilia. These face-to-face and face-to-face meetings will be conducted with group discussions and questions and answers between researcher, primary caregivers and children, with slideshows and films, and presentation of pamphlets.
Category
Lifestyle
2
Description
Control group: The control group will receive the routine treatment and care program only. After the 9th week (one month after the intervention group program), the quality of life questionnaire for hemophilia children and the Zarit care burden questionnaire will be completed for the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Baghaee 2 Ahvaz
Full name of responsible person
Dr. Shahnaz Rostami
Street address
Padada lands, avenue of knowledge, license plate 62, unit 2
City
Ahvaz
Province
Khouzestan
Postal code
5154550888
Phone
+98 61 3558 8269
Email
namakikhameneh.s@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badawi
Street address
Padada lands, avenue of knowledge, license plate 62, unit 2
City
Ahvaz
Province
Khouzestan
Postal code
5154550888
Phone
+98 61 3558 8269
Email
namakhkhameneh.s@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Rostami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ahwaz
City
Ahvaz
Province
Khouzestan
Postal code
5154550888
Phone
+98 61 3733 8331
Email
rostami-sh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Rostami
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ahwaz
City
Ahvaz
Province
Khouzestan
Postal code
5154550888
Phone
+98 61 3733 8331
Email
Rostami-sh@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Soulmaz Namaki KHameneh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Padada lands, street of a knowledge, license plate 62
City
Ahvaz
Province
Khouzestan
Postal code
6177983131
Phone
+98 615588269
Email
namakikhameneh.s@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Data can not be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results.
To whom data/document is available
Researchers and Academic Staff
Under which criteria data/document could be used
Access to tools and how to analyze tools is possible.