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The Effect of Teamwork Education Program on the Knowledge; Attitude and Parents Practice care of Children with Diabetes: a controlled Randomized clinical trial The Effect of Teamwork Education Program on the Knowledge; Attitude and Parents Practice care of Children with Diabetes: a Control Randomized controlled clinical trial

Protocol summary

Summary
The aims of current trial are to analyze the effect of team training program on parents' knowledge, attitude and performance of children with diabetic type I. Sixty parents (30 in each group) of type 1diabetic children with the inclusion criteria (the child with 6-12-year-old, not suffering from another chronic disease except type 1 diabetes, neither the child nor the parents infected with another psychological disease ,the parents' being literate,…) will be selected and randomly allocated into two groups: control (routine training) and intervention (team training). The exclusion criteria are: the parents not keeping cooperation in the study period, health care team being in the child's family and being absent more than one session in the training sessions. On the onset of the study, the parents' knowledge, attitude and performance score and the children's venous blood sample for determining HbA1C will be measured. The interventions for everyone will be held randomly according to the hospital routine training or team training based. In the intervention group, 5 team training sessions will be held by the trainer team (the pediatric endocrinologists, endocrinology ward nurse and nutritionist of the hospital) for each 5-diabetic child group with their parents. In the control group, routine ward training will be provided with an identical content. One and three month(s) after the training sessions, once parents' knowledge, attitude and performance questionnaires will be completed and the mean scores will be compared. Three months later, again the children's HbA1C will be measured and the variations will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201607314613N20
Registration date: 2016-09-06, 1395/06/16
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-09-06, 1395/06/16
Registrant information
Name
Sousan Valizadeh Dehkharghani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
009804134751706- 34796770
Email address
valizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-09-20, 1395/06/30
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Teamwork Education Program on the Knowledge; Attitude and Parents Practice care of Children with Diabetes: a controlled Randomized clinical trial The Effect of Teamwork Education Program on the Knowledge; Attitude and Parents Practice care of Children with Diabetes: a Control Randomized controlled clinical trial
Public title
The Effect of Teamwork Education Program on the Knowledge; Attitude and Parents Practice care of Children with Diabetes: a controlled Randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
the inclusion criteria:the child not suffering from another chronic disease except type 1 diabetes, neither the child nor the parents infected with another psychological disease ,the parents' being literate,…. The exclusion criteria are: the parents not keeping cooperation in the study period, health care team being in the child's family and being absent more than one session in the training sessions.
Age
From 6 years old to 12 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
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Address Pediatric Department of Nursing And Midwifery Faculty
City
TABRIZ
Postal code
51668-44199
Approval date
2016-07-04, 1395/04/14
Ethics committee reference number
R.TBZMED.REC.1395.295

Health conditions studied

1

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

Primary outcomes

1

Description
knowlege
Timepoint
Before and one month after the intervention
Method of measurement
Questionnaire

2

Description
Practice
Timepoint
Before and one month after the intervention.
Method of measurement
Questionnaire

3

Description
Attitude
Timepoint
Before and one month after the intervention.
Method of measurement
Questionnaire

Secondary outcomes

1

Description
HbA1C
Timepoint
Before and three month after the intervention.
Method of measurement
Taking Blood Sample

Intervention groups

1

Description
The intervention group 1: team training will be carried out by the trainer group (including the pediatric endocrinologists, endocrinology ward nurse and nutritionist of the hospital) for each group consisting of 5 diabetic children along with their parents ,which is made up of 30-45 m session .Training will be in the form of lecture, group debate and question-answer.
Category
Behavior

2

Description
The control group: routine training applying the identical content performed for diabetic sufferers in the hospital, that is, for each diabetic child along with their parents covering five 30-45 m training sessions. Training will be done as lecture, team debate and question-answer. Other treatment interventions
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
17 Sharivar hospeital
Full name of responsible person
Tahereh Hassanpour
Street address
17 Sharivar hospeital, Siyadati Av., Namjoo St., Rasht
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Deputy of Research and Technology, Tabriz University of Medical Sciences ,Golgasht street
City
Tabriz
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 of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Tahereh Hassanpour
Position
Student of Master degree pediatericNursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery , Shariati jaSouth Street , Tabriz , Iran Tabriz East Azarbaijan Iran, Islamic Republic Of
City
Tabriz
Postal code
51668-44199
Phone
+98 13 3336 9391
Fax
Email
taherehhassanpour
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Sousan Valizadeh
Position
Associate Professor of Child health and Neonatal Intensive Care Department, PhD in Nursing Education
Other areas of specialty/work
Street address
School of Nursing and Midwifery , Shariati South Street , Tabriz , Iran
City
Tabriz
Postal code
51668-44199
Phone
+98 41 3479 0364
Fax
+98 41 3479 6969
Email
valizades@tbzmed.ac.ir valizadehsousan13@gmail.com http://researchvice.tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Tahereh Hassanpour
Position
Student of Master degree pediatericNursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery , Shariati jaSouth Street , Tabriz , Iran Tabriz East Azarbaijan Iran, Islamic Republic Of
City
Tabriz
Postal code
51668-44199
Phone
+98 13 3336 9391
Fax
Email
taherehhassanpour@yahoo.comnurs.hassanpour@gmail.com
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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