Main goal of the study:The effect of continuous care model on control of signs & recurrence among the children with Nephritic Syndrome,
Inclusion criteria:
1- Passing at least 3 months from nephritic syndrome onset in the children
2- Not to be affected child and his or her parents to the problems such as mental retardation, mental illness...
3- The consent of child and his or her parents to participate in this study
Exclusion criteria:
1- If during the study, sensitive and dependent nephritic syndrome disease in the patient changes to resistant nephritic syndrome
2-If patient and his or her parents are affected by any physical disease associated with nephritic syndrome during the study
3- If patient and his or her parents participate only in two educational sessions instead of six sessions
The study population: Children 7 to 12 years old with nephritic syndrome are referring to the specialized clinic of Abazar Hospital
The sample size:66 children with nephritic syndrome
Interventional Study:Continuous care model
Time of interventional study:Generally six months is considered for this intervention.Continuous care model is included four stages:
1-Orientation
2-Sensitization
3-Control
4-Evaluation
Generally, 6 weeks considered for orientation and sensitization stages and And the rest of the 6 months considered would be paid for the remaining two phases.
The primary outcome:Values obtained from the control of the dependent variables are recorded before the intervention in the two groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012070810209N1
Registration date:2013-03-05, 1391/12/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-05, 1391/12/15
Registrant information
Name
Simin Madhooshi Mazraeei
Name of organization / entity
Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1416 2687
Email address
s_madhooshi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences Research
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Continuous Care Model On Control of Signs & Recurrence Among The Children With Nephritic Syndrome
Public title
Control of Signs & Recurrence of Nephritic Syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1- Passing at least 3 months from nephritic syndrome onset in the children
2- Not to be affected child and his or her parents to the problems such as mental retardation, mental illness...
3- The consent of child and his or her parents to participate in this study
Exclusion criteria:
1- If during the study, sensitive and dependent nephritic syndrome disease in the patient changes to resistant nephritic syndrome
2-If patient and his or her parents are affected by any physical disease associated with nephritic syndrome during the study
3- If patient and his or her parents participate only in two educational sessions
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ahvaz Jundishapur University of Medical Sciences and Health Services
Street address
Ahvaz,university city,Vice Chancellor for Research and Technological Development Ahvaz Jundishapur University of Medical Sciences and Health Services,Ground Floor
City
Ahvaz
Postal code
15794-61357
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
91109- U
Health conditions studied
1
Description of health condition studied
Nephrotic Syndrome
ICD-10 code
N04
ICD-10 code description
Isolated proteinuria with specified morphological lesion
Primary outcomes
1
Description
TG,Chol
Timepoint
before & after study
Method of measurement
A blood test & check the lipid
2
Description
Proteinuria
Timepoint
during and after the study
Method of measurement
A urin test & check the Proteinuria
3
Description
Body weight
Timepoint
before & after study
Method of measurement
Using analog scale SECA mark
4
Description
Blood presure
Timepoint
before & after study
Method of measurement
Using a pressure gauge ALPK2 model
5
Description
Knowledge
Timepoint
before & after study
Method of measurement
questionnaire regarding the knowledge rate of parents about symptoms of the nephrotic syndrome disease recurrence
6
Description
Recurence and control of signs of nephrotic syndrom
Timepoint
Before the intervention, and three months after intervention
Method of measurement
Bp measured by a counterclockwise pressure cuff on Mark ALPK2 on mmHg,BW measured byBranded analogue scales SECA, Measurement of lipid per dl / mg,Urine test for the presence of protein in the urine using reagent strips in scale, 0 to + + + + partial,To measure the reliability and validity of a questionnaire to assess knowledge has been approved by the Faculty of Medical Sciences.
Secondary outcomes
empty
Intervention groups
1
Description
Case group :
After collecting basic data, a questionnaire on demographic characteristics and also measuring blood pressure, Triglyceride and Cholesterol, weight and urine tests , continuous care model which is an in turn educational model with a six months follow up ans it's effect on the mentioned variables, will be implemented in the international group.
Category
Other
2
Description
Control group :
In this study after collecting demographic data and measuring of body weight, blood pressure, triglyceride and cholesterol and record of recurrence, Continuous Care Model
won't be done on control group. Finally, values of the body weight, blood pressure, triglyceride and cholesterol & record of
recurrence from tow groups ) will check and then will compare with each other.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrology Clinic Medical Center - Pediatrics, Abuzar
Full name of responsible person
Miss Ashraf Al Sadat Hakim
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences,School of Nursing and Midwifery, Golestan, Ahvaz, Kuzeatan
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Miss Ashraf Al Sadat Hakim
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences,School of Nursing and Midwifery, Golestan, Ahvaz, Kuzeatan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ashraf Al Sadat Hakim
Position
Master of Nursing
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences,School of Nursing and Midwifery, Golestan, Ahvaz, Kuzeatan
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1373 8261
Fax
+98 61 1373 8333
Email
Hakim3448200@yahoo.comhakim-a@ajums.ac.ir
Web page address
http://fnuring.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ashraf Al Sadat Hakim
Position
Master 0f nursing
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences,School of Nursing and Midwifery, Golestan, Ahvaz, Kuzeatan
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1373 8261
Fax
+98 61 1373 8333
Email
Hakim3448200@yahoo.c0mhakim-a@ajum.ac.ir
Web page address
http://fnursing.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ashraf Al Sadat Hakim
Position
Master of nursing,Faculty Member
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences,School of Nursing and Midwifery, Golestan, Ahvaz, Kuzeatan
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1373 8261
Fax
+98 61 1373 8333
Email
Hakim3448200@yahoo.comhakim-a@ajum.ac.ir
Web page address
http://fnursing.ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)