Protocol summary

Summary
objectives: Diabetes is One of the most common chronic metabolic diseases in the world and our country .it is not curable but it can be controlled. control of diabetes is independing adherence of treatment regime containing medication treatment, dietary regime, sports activities. It is possible with education of children and families. The aim of this study is to determine the effect of family centered empowerment model on the treatment regime of school age children. design: This study is a clinical trial on a 7-12 year old children with type 1 diabetes and their families .siting and conduct A total of 50 patients and their parents, referred to Diabetes Clinic of Golestan Hospital have been chosen to intervention with the ethical standards and criteria. They were divided randomly into two groups.participants including major eliglibity criteria: Minimum age 7 years and maximum age 12 years, two months of their diagnosis is past, before no educated, no other acute disease during the study. Inclusion exit: If they would like to be excluded from the study, study dont have no financial loss to them, along with the patient's is the main caregiver.Interventions: The case group educated with family centerd empowerment model during four sessions 2 hour. Data were collected with questionnaires, included demographics, physical activity, knowledge, adherence to dietary and medication adherence Before the intervention in the both groups and immediately after the intervention and 2 months after the intervention, the case group were completed and the data evaluated with spss20 software and descriptive and analytical statistical tests .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013031710244N2
Registration date: 2013-06-08, 1392/03/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-08, 1392/03/18
Registrant information
Name
Farkhondeh Mahmoodi
Name of organization / entity
Jondishapoor University
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8621
Email address
mahmoodifa@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Jondishapoor university of Medical science,University City, Golestan Booolvar, Ahvaz, KHouzestan, Iran
Expected recruitment start date
2012-10-11, 1391/07/20
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family centered empowerment model on the treatment regime of diabetes school age children
Public title
The effect of family centered empowerment model on the treatment regime of diabetes school age children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: Minimum age 7 years and maximum age 12 years, two months of their diagnosis is past, before no educated, no other acute disease during the study. Inclusion exit: If they would like to be excluded from the study, studydont have no financial loss to them, along with the patient's is the main caregiver
Age
From 7 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Ethics committee of Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Golestan Boolvar, Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2012-10-27, 1391/08/06
Ethics committee reference number
EHT-604

Health conditions studied

1

Description of health condition studied
insulin- dependent diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Parental Knowledge
Timepoint
Before intervention -Immediately intervention- Two months after the intervention
Method of measurement
Knowledge Questionnaire

2

Description
Children Knowledge
Timepoint
Before intervention -Immediately intervention- Two months after the intervention
Method of measurement
Knowledge Questionnaire

3

Description
Medical Regime
Timepoint
Before intervention -Immediately intervention- Two months after the intervention
Method of measurement
Medical Regime Questionnaire

Secondary outcomes

1

Description
Insulin Injection
Timepoint
Before intervention - Immediate ofter intervention- two months after the intervention
Method of measurement
Practical assessment

2

Description
Dietary Adherence
Timepoint
before intervention - Ofter intervention- Two months after the intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
In the case group during educational meeting 4 meeting, about 2educational meeting about diseases, symptoms, diet, exercise and 2educational meeting practically showing how to inject insulin, glucose check, How to measure insulin,determine the food units perform
Category
Prevention

2

Description
In the control group no intervention
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital Clinic
Full name of responsible person
Farkhondeh Mahmoodi
Street address
Emam Street, NoorAbad, Fars
City
Nnoorabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Jundishapur University of Medical Sciences,Golestan Boolvar Ahvaz, Ir
Full name of responsible person
Mostafa Feghhi
Street address
The ground floor, Vice chancellor for research, Jundishapur University of Medical Sciences, Golestan Boolvar,Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Jundishapur University of Medical Sciences,Golestan Boolvar Ahvaz, Ir
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
Jundishapur university of Medical Sciences
Full name of responsible person
Farkhondeh Mahmoodi
Position
Master Nursing Student
Other areas of specialty/work
Street address
Jundishapur university of Medical Sciences,Golestan Boolvar, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8621
Fax
Email
Mahmoodifa57@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jundishapur university of Medical Sciences
Full name of responsible person
Farkhondeh Mahmoodi
Position
Master Nursing Student
Other areas of specialty/work
Street address
Jundishapur university of Medical Sciences, Golestan Boolvar,Ahvaz,Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8621
Fax
Email
Hakim3448200@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Jundishapur university of Medical Sciences
Full name of responsible person
Farkhondeh Mahmoodi
Position
Nursing graduate
Other areas of specialty/work
Street address
Jundishapur university of Medical Sciences, Golestan Boolvar,Ahvaz,Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8621
Fax
Email
Mahmoodifa@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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