The effect of education based on continuous care model for mothers is determined on the treatment compliance of children with epilepsy
Design
It is a controlled clinical trial. Sampling is done in an convenient based on the conditions of entry into the study and the samples are allocated to the control and intervention groups by random block method (4) and based on the randomization list. The randomization list is prepared using R software
Settings and conduct
The intervention group is divided into three sub-groups of 10 people and 4 stages of familiarization, sensitization, control and evaluation are implemented in the intervention group in the educational classroom of Amirkabir Hospital. Familiarization: This stage is a 60-45 minute session. Sensitization: This stage is done during 4 sessions of 30 to 45 minutes (once a week for a month). Control: Telephone follow-ups for two months
Participants/Inclusion and exclusion criteria
Inclusion criteria: The child has epilepsy for at least three months based on the doctor's diagnosis
Age group 6 to 18 years
The absence of children and parents suffering from problems such as mental retardation
Taking at least one antiepileptic drug by the patient
Exclusion criteria: child or parents suffering from problems such as mental retardation
Intervention groups
In the control group, there is no intervention, and the questionnaires are completed at the same time as the intervention group and after the completion of the training, the control group is provided. Intervention: familiarization: in a 60 to 45 minute session. Sensitization: It is done during 4 sessions of 30 to 45 minutes (once a week for a month). Actions are in the form of group discussions, lectures, questions and answers, and presentation of educational pamphlets. Control: two months follow-up by phone.
Main outcome variables
Reducing disease recurrence and increasing recovery and treatment follow-up
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240217061038N1
Registration date:2024-05-28, 1403/03/08
Registration timing:retrospective
Last update:2024-05-28, 1403/03/08
Update count:0
Registration date
2024-05-28, 1403/03/08
Registrant information
Name
Zahra Rangriz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 333 0800
Email address
z.rankriz@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-28, 1402/12/09
Expected recruitment end date
2024-03-29, 1403/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on continuous care model for mothers, on the treatment compliance of children with epilepsy
Public title
The effect of teaching mothers on the treatment compliance of children with epilepsy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A child suffering from epilepsy for at least three months based on a doctor's diagnosis
Age group 6 to 18 years
The absence of children and parents from problems such as mental retardation
Taking at least one antiepileptic drug by the patient
Exclusion criteria:
Children and parents suffering from problems such as mental retardation
Age
From 6 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done in an easy way based on the conditions of entry into the study, and the samples are allocated to the control and intervention groups based on the random block method (of 4) and based on the randomization list provided to the researcher by the statistician. The randomization list is prepared using R software. The intervention group is a and the control group is b. In front of the number of each column, there is one of the letters a or b. The table is random and according to this, people are placed in two groups.
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
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Hazrat Masoumeh dormitory
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2024-02-14, 1402/11/25
Ethics committee reference number
ir.arakmu.rec.1402.214
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G99
ICD-10 code description
Other disorders of nervous system in diseases classified elsewhere
Primary outcomes
1
Description
Adherence to treatment
Timepoint
Before the start of the intervention and immediately after the end of the intervention
Method of measurement
Questionnaire of adherence to Madanlo treatment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: The intervention group is divided into three sub-groups of 10 people due to ease of access and coordination in holding group classes. Then the training intervention based on the continuous care model including 4 stages of familiarization, sensitization, control and evaluation is implemented in the intervention group. Familiarization: The purpose of this stage is to correctly recognize the problem, create motivation and feel the need and necessity of the follow-up process in mothers. This stage takes place in a 60 to 45 minute session. Sensitization: This stage is done during 4 sessions of 30 to 45 minutes (once a week for a month). The actions that are carried out are in the form of group discussions, lectures, questions and answers, and presentation of educational pamphlets. Understanding the nature of the disease, meeting the needs, explaining about the disease and its complications, the need to pay attention to the treatment, including drug therapy, exercise and activity, diet, etc., will be the most important topics discussed. Control: For two months, telephone follow-ups will be conducted in connection with how to use the trainings. If necessary, face-to-face meetings are also held. Evaluation: At the end of the work, the status of care provided and treatment compliance will be checked through a treatment compliance questionnaire during one session.
Category
Other
2
Description
Control group: Control group: In the control group, there is no intervention and only the questionnaires are filled at the same time as the intervention group, and the trainings are provided to the control group after the work is completed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital clinic
Full name of responsible person
Zahra rangriz
Street address
Alam Al Hadi St
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 919 333 0800
Email
Z.rankriz@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Daud Hekmat Po
Street address
Basij square
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3502
Email
Z.rankriz@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Zahra rangriz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hazrat Masoumeh's dormitory
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 919 333 0800
Email
Z.rankriz@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra rangriz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hazrat Masoumeh's dormitory
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 919 333 0800
Email
Z.rankriz@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra rangriz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hazrat Masoumeh's dormitory
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 919 333 0800
Email
Z.rankriz@arakmu.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
Yes - There is 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
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
The information related to the main outcome of the study can be shared after the results are printed
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
For researchers working in academic institutions
Under which criteria data/document could be used
There is no special condition
From where data/document is obtainable
Zahra Rangriz Email: z.rankriz.ac.ir
What processes are involved for a request to access data/document