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The impact of family empowerment model on life quality of children with epilepsy in selected centers of Shiraz and Kerman universities of medical sciences, 2018

Protocol summary

Study aim
This study aims to conduct the family empowerment program.
Design
The participants will be divided into two groups via permuted block randomization. Then, groups A and B will be assigned to intervention and control groups, respectively. The two groups will be required to fill out the QOLCE questionnaire in the first session.
Settings and conduct
A total of 80 parents who have children with epilepsy referred to Besat Clinic in Kerman and Imam Reza Clinic in Shiraz will be selected purposely according to the inclusion criteria of the research. After obtaining their written informed consent forms for taking part in the study, they will be randomly allocated to intervention (n=40) and control (n=40) groups.
Participants/Inclusion and exclusion criteria
Parents who have children of 3-7 years old suffering from epilepsy with passage of at least six months from disease diagnosis and treatment onset who have to be followed up for at least a year according to their physicians’ diagnoses and medical records, willingness to participate in the study, signing written informed consent forms to take part in the research, having diploma to Bachelor’s degrees, having sufficient monthly income, not having participated in similar educational programs, not suffering from physical and mental disorders disturbing their daily living activities, and not working in health and treatment fields.
Intervention groups
The intervention program and the empowerment of parents in the test group will include two training sessions. Considering ethics, the control group parents will receive the educational pamphlets after completing the questionnaire.
Main outcome variables
Conducting the family empowerment program will result in responsibility, more efficient interaction with the treatment team, better response to treatment, and reduction of treatment costs, length of hospital stay, and disease complications.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160618028524N3
Registration date: 2018-11-26, 1397/09/05
Registration timing: registered_while_recruiting

Last update: 2018-11-26, 1397/09/05
Update count: 0
Registration date
2018-11-26, 1397/09/05
Registrant information
Name
Hamid Nemati
Name of organization / entity
Child Neurologist, Assistant Professor of Shiraz University of Medical Sciences, Shiraz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4332
Email address
nematih@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-26, 1397/09/05
Expected recruitment end date
2019-02-14, 1397/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of family empowerment model on life quality of children with epilepsy in selected centers of Shiraz and Kerman universities of medical sciences, 2018
Public title
The impact of family empowerment model on life quality of children with epilepsy in selected centers of Shiraz and Kerman universities of medical sciences, 2018
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Parents of children aged 3-7 years with epilepsy who have 6 months of diagnosis and initiation of treatment, and according to the doctor's records and diagnosis, need to go and follow up for at least one year. Acquiring informed consent and willingness to participate in research by parents Having Diploma education to bachelor's degree and enough monthly income Not participating in the same educational program The absence of physical and psychological disruption of daily activities Parents are not personnel and health care providers
Exclusion criteria:
Parents of children hospitalized with febrile of convulsion
Age
No age limit
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
Sampling will be done via permuted block randomization. In doing so, a digit will be randomly selected among random numbers and then, 40 blocks with block size of two will be chosen successively as follows: AB (4-0) and BA (9-5). After that, groups A and B will be allocated to intervention and control groups, respectively.
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
Ethic's committee of Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, opposite Felestine St. Zand St. Shiraz, Fars
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2018-10-02, 1397/07/10
Ethics committee reference number
IR-SUMS.REC.1397.565

Health conditions studied

1

Description of health condition studied
The family empowerment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The main outcome measures of this study are executing the family empowerment program and enhancing the life quality of children suffering from epilepsy. The data will be collected using the Quality of Life in Children with Epilepsy (QOLCE) questionnaire, which is a specific instrument for assessing such children’s quality of life. This instrument has been derived from Health-Related Quality of Life (HRQoL) questionnaire, which is used to evaluate healthcare and medical interventions in both clinical and social domains.
Timepoint
The QOLCE questionnaire will be completed by the two groups in the first session. The intervention group will receive the family empowerment program over two educational sessions. In the first session, the parents will be trained regarding the process, clinical symptoms, diagnosis, and probable complications of the disease through question and answer and educational pamphlets. The second session will involve face-to-face training during seizure, available treatments, recovery process after treatment, and necessity for long-term follow-ups. The training will be carried out both individually and in groups using educational pamphlets. After a month, the questionnaire will be completed by the parents again. Considering ethics, the control group parents will receive the educational pamphlets after completing the questionnaire.
Method of measurement
The data will be collected using the QOLCE questionnaire, which is a specific instrument for assessing quality of life in children suffering from epilepsy. This instrument has been derived from HRQoL questionnaire, which is used to evaluate healthcare and medical interventions in both clinical and social domains.Children with seizure disorders are normally faced with an increased risk of behavioral and emotional problems, familial and social decline, and lower quality of life. QOLCE evaluates such children’s quality of life in four dimensions, namely cognitive function (22 items), emotional function (17 items), social function (7 items), and physical function (9 items). The items are responded via a 5-point Likert scale. Accordingly, scores 0, 25, 50, 75, and 100 represent very low, low, average, high, and very high functions, respectively. The reliability of QOLCE was approved by Goodwin et al. in 2015.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group includes the parents who have children with epilepsy, meet the inclusion criteria, and are willing to participate in the research. In the first session, the parents will be required to complete the QOLCE questionnaire. The family empowerment intervention is carried out through two educational sessions. In the first session, the parents will be trained regarding the process, clinical symptoms, diagnosis, and probable complications of the disease through question and answer and educational pamphlets. The second session will involve face-to-face training during seizure, available treatments, recovery process after treatment, and necessity for long-term follow-ups. The training will be carried out both individually and in groups using educational pamphlets. After a month, the questionnaire will be completed by the parents again.
Category
Lifestyle

2

Description
Control group: After selecting the control group participants, they will be required to complete the QOLCE questionnaire in the first session. Considering ethics, the control group parents will receive the educational pamphlets after completing the questionnaire. After a month, the questionnaire will be completed by the parents again.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Clinic, Namazi Hospital, Dastghieb Hospital
Full name of responsible person
Dr.Hamid .Nemati
Street address
Pediatric neurology department, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7187649635
Email
nematih@sums.ac.ir

2

Recruitment center
Name of recruitment center
Besat Clinic
Full name of responsible person
Zahra Mahdavi Khanouki
Street address
Avenue of the Sun at the Alley 78 - Besat Hospital 4 (Samen al-Hajj)
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3273 4509
Email
zahra.mahdavi@iauk.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vice Chancellor for Researc, Shiraz University of Medical Sciences
Street address
Vice-Chancellery for Research and Technology, Seventh Floor, Central Building of Shiraz University of Medical Sciences, Zand Avenue, Shiraz
City
Shiraz
Province
Fars
Postal code
7184516278
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Islamic Azad University
Full name of responsible person
Zahra Mahdavi Khanouki
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr Blvd., Islamic Azad University, Kerman Branch
City
Kerman
Province
Kerman
Postal code
7635131167
Phone
+98 343321004350
Fax
Email
zahra.mahdavi@iauk.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Hamid Nemati
Position
Pediatric Neurologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Neurology Ward, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7187649635
Phone
+98 71 3647 4298
Fax
Email
Nematih@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Hamid Nemati
Position
Pediatric Neurologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Neurology Ward, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7187649635
Phone
+98 71 3647 4298
Fax
Email
Nematih@sums.ac.ir
Web page address

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
A large proportion of the data, including the information related to the main outcome measure, will be shared after the end of the study.
When the data will become available and for how long
After the end of the study
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
Researchers in academic and scientific institutions can use the present study results for their scientific and research works after gaining permission from the authors.
From where data/document is obtainable
meshham5@gmail.com zahra.mahdavi@iauk.ac.ir
What processes are involved for a request to access data/document
Researchers in academic and scientific institutions can use the present study results for their scientific and research works after gaining permission from the authors.
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