The purpose of this study was determination the effects of family centered care for the management of glucose control in children with insulin-dependent diabetes attending to the Diabetes Research Center of Hamadan. Methods and materials: Quasi-Experimental one-group pretest-post test design. The study population: Children with insulin-dependent diabetes attending to the Diabetes Research Center of Hamadan with their main caregivers. Inclusion criteria: 1) Child has 10- 14 years old; 2) Child has not any other chronic diseases; 3) Child and his/her main caregiver have not any mental or cognitive illness ; 4) Main caregivers be literate. Exclusion criteria: 1) One member of the family has a position in health teams; 2) Child and his/her significant caregiver be absent in more than one session. Sample size: 40 diabetic children and their main caregivers. Interventions: Four sessions will be conducted for each group consist of 10 diabetic children with their main caregivers. Therefore, 16 education sessions will be done. The time of each session will be 30 to 40 minutes. The methods of teaching will be lecture, group discussion, questions and answers and the role playing. Outcome: using questionnaires which will be filled by the child and his/her main caregiver, one week before and one month after intervention, bounding to the diet, bounding to the principles of insulin therapy, how to measure blood glucose, and physical activity programs will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013033112879N1
Registration date:2013-05-26, 1392/03/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-26, 1392/03/05
Registrant information
Name
Seyedeh Zohreh Mortazavi
Name of organization / entity
Faculty of nursing and midwifery, Hamadan University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0527
Email address
z.mortazavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family centered care on management of diabetic children's blood glucose control in Research Center for Diabetes of Hamadan - Iran
Public title
Family-centered care in the management of diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1) At least six months passed of the child's diabetes diagnosis; 2) Child has 10-14 years old; 3) Child has not any other chronic diseases; 4) The child’s family must live in Hamadan; 5) ) Child and his/her significant caregiver have not any mental or cognitive illness; 6) Main caregivers be literate; 7) The child and his/her significant caregiver did not participate in other formal training programs about diabetes within the last month; 8) Parents do not have experience of diabetes in own or previous child. Exclusion criteria: 1) One member of the family has a position in health teams; 2) Child and his/her significant caregiver be absent in more than one session
Age
From 10 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Human Review Board, Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh st, Hamadan
City
Hamadan
Postal code
65178
Approval date
2013-04-15, 1392/01/26
Ethics committee reference number
16/35/9/78/پ/د
Health conditions studied
1
Description of health condition studied
Diabetes of type1
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
observance diet
Timepoint
a week before and one month after intervention
Method of measurement
questionnaire managing blood glucose control
2
Description
observance principles of insulin therapy
Timepoint
a week before and one month after intervention
Method of measurement
questionnaire managing blood glucose control
3
Description
how measure blood glucose
Timepoint
a week before and one month after intervention
Method of measurement
questionnaire managing blood glucose control
4
Description
physical activity programs
Timepoint
a week before and one month after intervention
Method of measurement
questionnaire managing blood glucose control
Secondary outcomes
1
Description
blood glucose
Timepoint
a week before and one month after intervention
Method of measurement
form of blood glucose levels
Intervention groups
1
Description
Four sessions will be conducted for each groups consisted of 10 diabetic children with their significant caregivers. Therefore 16 education sessions will be done. The time of each session will be 30 to 40 minutes.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Diabetes
Full name of responsible person
Seyedeh Zohreh Mortazavi, Msc student of pediatric nursing
Street address
Myrzad Eshghi st,Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vic-Chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Haidar Tavilani
Street address
Hamadan University of Medical Sciences,Shahid Fahmideh Ave, Hamadan
City
Hamadan
Grant name
از محل یک درصد بودجه ی طرح های تحقیقاتی دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-Chancellor for research, Hamadan 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
Faculty of nursing and midwifery,Hamadan University of Medical Sciences
Full name of responsible person
Seyedeh Zohreh Mortazavi
Position
MSC student of pediatric nursing
Other areas of specialty/work
Street address
Faculty of nursing and Midwifery,Hamadan University of Medical Sciences, Shahid Fahmideh Ave, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1383 0527
Fax
+98 81 1838 0447
Email
z.mortazavi90@yahoo.com z.mortazavi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of nursing and Midwifery, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Cheraghi
Position
PhD in Nursing
Other areas of specialty/work
Street address
Faculty of nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 0527
Fax
+98 81 1838 0447
Email
f_cheraghi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of nursing and Midwifery, Hamadan University of Medical Sciences
Full name of responsible person
Seyedeh Zohreh Mortazavi
Position
MSC student of pediatric nursing
Other areas of specialty/work
Street address
Faculty of nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave, Hamadan
City
Hamadan
Postal code
65178
Phone
+98 81 1838 0527
Fax
+98 81 1838 0447
Email
z.mortazavi90@yahoo.com z.mortazavi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)