Determining the Effect of Combined Training on Improving Knowledge and Performance of Parents with Chronic Kidney Failure
Design
Randomized clinical trial with control group. Sample size: 42
Settings and conduct
The research environment in this study is the clinics of Nephrology clinics of Abuzar Hospital in Ahvaz. The study was conducted on pre-test and post-test after one month of educational intervention.
Participants/Inclusion and exclusion criteria
Entry requirements;. Parents have the ability to complete the questionnaire and participate in the training program (mental-rational)
Exit Conditions; Non-participation in more than one session of training sessions-For any reason the child needs to be admitted
Intervention groups
The random samples are divided into two groups of intervention and control. The intervention group receives training but does not receive any training.
Main outcome variables
Combined education; Awareness; Family function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181211041928N1
Registration date:2018-12-27, 1397/10/06
Registration timing:retrospective
Last update:2018-12-27, 1397/10/06
Update count:0
Registration date
2018-12-27, 1397/10/06
Registrant information
Name
zainab eydivandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4322 4819
Email address
eydivandi.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-19, 1397/05/28
Expected recruitment end date
2018-08-28, 1397/06/06
Actual recruitment start date
2018-08-29, 1397/06/07
Actual recruitment end date
2018-09-29, 1397/07/07
Trial completion date
2018-10-29, 1397/08/07
Scientific title
The Effect of Combined Education on Improving Level of Knowledge and Performance of parents have a child with Chronic Kidney Failure
Public title
The Effect of Combined Education on Improving Level of Knowledge and Performance of parents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Parents want to participate in research
Parents have not previously participated in educational groups
Parents have the ability to complete the questionnaire and participate in the educational program (mental-rational)
Do not have a history of uncontrolled underlying conditions such as epilepsy, stress and chronic anxiety, etc. that affect the outcome
At least 6 months have passed since the diagnosis of the disease
The physician has a medical appointment in relation to the illness
Exclusion criteria:
Not attending more than one session of training sessions
For any reason the child needs to be admitted
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:
42
Actual sample size reached:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients to intervention and control groups was done by randomized block designer 4 by statistician.
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 the University of Ahvaz Jundishapur University of Medical Sciences
Street address
No.7; West Goolestan Ave; Golestan Blvd; AhvazTown
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Approval date
2018-07-14, 1397/04/23
Ethics committee reference number
IRAJUMS.REC.1397.323
2
Ethics committee
Name of ethics committee
The Ethics Committee of the University of Ahvaz Jundishapur University of Medical Sciences
Street address
No.7; West Goolestan Ave; Golestan Blvd; AhvazTown
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Approval date
2018-07-14, 1397/04/23
Ethics committee reference number
IRAJUMS.REC.1397.323
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
I13.11
ICD-10 code description
Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal disease
Primary outcomes
1
Description
Combined training
Timepoint
Before intervention, 1 month after intervention
Method of measurement
According to the score of the family's knowledge and practice questionnaire
Secondary outcomes
1
Description
Family awareness
Timepoint
Before intervention, 1 month after intervention
Method of measurement
Questionnaire
2
Description
Family function
Timepoint
Before intervention, 1 month after intervention
Method of measurement
Standard family function questionnaire
Intervention groups
1
Description
Intervention group: Intervention group: education; teaching method using lecture and video tutorials (teaching about the definition and cause of illness, symptoms, complications, prognosis, treatment and care).
Category
Behavior
2
Description
Control group: Control group: Perform pre-test, no training, educational videos. A questionnaire is provided to them one month later.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Abuzar Hospital
Full name of responsible person
Shahnaz Rostami
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8394
Email
Rostami-sh@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Ahvaz Abuzar Hospital
Full name of responsible person
Shahnaz Rostami
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8394
Email
Rostami-sh@ajums.ac.ir
3
Recruitment center
Name of recruitment center
Abuzar Hospital
Full name of responsible person
Shahnaz Rostami
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
Rostami-sh@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shnaz Rostami
Street address
Golestan Highway, Ahwaz University of Medical Sciences, Nursing Midwifery Faculty
City
َ Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
GogestanjPsPital@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahwaz 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
Shahnaz Rostami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan, Kargar Town, Faculty of Nursing Midwifery
City
َAhvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 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
zainab Eydivandi
Position
Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan, Kargar Town, Faculty of Nursing Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61432224819
Email
eydivandi.z@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
zainab Eydivandi
Position
Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan Highway, Ahwaz University of Medical Sciences, Nursing Midwifery Faculty
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Email
eydivandi.z@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Information on the primary outcome and the secondary outcome is 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
Data is only available to researchers working in universities.
Under which criteria data/document could be used
It is available to assess the knowledge and performance of families.
From where data/document is obtainable
The data are available in the archives of theses of the Faculty of Nursing and Midwifery of Ahwaz University of Medical Sciences. School-nm@ajums.ac.ir
What processes are involved for a request to access data/document
The application must first be sent to the Ahwaz University of Medical Sciences. After being examined by the Vice-Chancellor, the application will be sent to the Nursing Midwifery Faculty, and will be sent to the Nursing Midwifery Library after being submitted to the library.