Comparison of the Effectiveness of Peer-led and Family-based Education on Self-Care in Diabetic Adolescents
Design
Classified block randomization, not blinded, sham controlled clinical trial with three groups (family, peer and control) design of 180 diabetic adolescent, enrolled and followed for three months.This study will be conducted at Diabetes clinic in Children's Medical Center and Iranian Diabetes Society in Tehran. All parents and all diabetic adolescents in the two centers will not have any contact together.
Settings and conduct
This study will be conducted at Diabetes clinic in Children's Medical Center and Iranian Diabetes Society in Tehran. First, the conditions for entering the study will be explained for the patient clearly and, if desired, the informed consent form will be completed.This study will be done as not blinded study.To hide the intervention group, the type of intervention will be written on a sheet of paper and will be inserted into opaque and consecutively-numbered envelopes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 12-16 years; Being diabetic type1; Diabetic diagnosis at least for past 1 year; having an active parent
Exclusion criteria:The absence of both adolescence and parent in educational class; hospitalization; incidence of Ketoacidosis or diabetic coma during the study period; having hemoglobinopathy, anemia, reticulocytosis and uremia during study
Intervention groups
Intervention group1: (Family education): conducting Six Family educational sessions by the researcher (for 4 groups of 15) with a one-week interval
Intervention group2: (Education through peer): conducting Six educational sessions (with a one-week interval) by a peer participant for 4 groups of 15 Diabetic Adolescents
Control group: will not receive any interventions Main
Main outcome variables
Self care behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140604017972N13
Registration date:2018-06-19, 1397/03/29
Registration timing:retrospective
Last update:2018-06-19, 1397/03/29
Update count:0
Registration date
2018-06-19, 1397/03/29
Registrant information
Name
Zahra Godarzi
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4407
Email address
godarziz@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2018-01-20, 1396/10/30
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Peer-led and Family-based Education on Self-Care in Diabetic Adolescents
Public title
Effect of Education by Family and Peer on Self-Care in Diabetic Adolescents
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 12-16 years
Being diabetic type 1
Diabetic diagnosis at least for past 1 year
Signed the informed consent form
Ability to read and write
Being single
Having an active parent
Does not have other medical history
Exclusion criteria:
The absence of both adolescence and parent in educational class
Hospitalization during the Study
Incidence of Ketoacidosis or diabetic coma during the study period
Membership one of a family member in the health team
The occurrence of a critical event in the family.
Having hemoglobinopathy, anemia, reticulocytosis and uremia during study
Unwillingness to continue the study
Not fully participating in the conducted sessions for both groups
Age
From 12 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Actual sample size reached:
180
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the classified block randomization will be used. According to the sample size of 180، 30 blocks will be produced using the online site (www.sealedenvelope.com).
Then, to hide the intervention group, the type of intervention (peer-led group, family based group, control group) will be written on a sheet of paper and will be inserted into opaque and consecutively-numbered envelopes.Randomizing at the individual level.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Ethics Committee School of Nursing and Midwifery, Tehran Medical Sciences
Secondary trial Id
IR.TUMS.FNM.REC.1396.2176
Registration date
2017-04-30, 1396/02/10
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, eastern Nosrat St, Tohid square, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-05-01, 1396/02/11
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2176
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Self care behavior
Timepoint
before intervention and 3 months after
Method of measurement
self-care behaviors (SMOD-A) questionnaire
Secondary outcomes
1
Description
HBA1C
Timepoint
before intervention and 3 months after intervention
Method of measurement
Hemotology test by spectrofotometr
Intervention groups
1
Description
Intervention group1: Family education: in the family education group, patient accompanied will receive 6 sessions 120 minutes training.
Category
Lifestyle
2
Description
Intervention group2: Education through peer:In the peer education group, 4 patients will be selected as the peer group leader.The peer group is divided into four groups, and each of these four individuals is randomly assigned to a group of 15 people.Then, with the collaboration of the peer group, the training sessions will be held for intervention groups in 6 sessions of 120 minutes
Category
Lifestyle
3
Description
Control group: receiving no educational intervention
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes clinic in Children's Medical Center
Full name of responsible person
Neda Salimi
Street address
No. 62, Keshavarz Blvd., Street doctor Mohammad Gharib., Children's Medical Center.,Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6692 7171
Email
godarziz@tums.ac.ir
2
Recruitment center
Name of recruitment center
Iranian Diabetes Society (IDS)
Full name of responsible person
Neda Salimy
Street address
No. 27, Ramin Malakooti Street., Patris Lomumba- Satarkhan Street.
City
Tehran
Province
Tehran
Postal code
1443914661
Phone
+98 21 8825 3113
Email
godarziz@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Neda salimi
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, eastern Nosrat St, Tohid square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
godarziz@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Neda Salimi
Position
Master of Pediatric Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, eastern Nosrat St, Tohid square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6692 7171
Email
salimyneda@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Godarzi
Position
Master of Science/Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, eastern Nosrat St, Tohid square,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6692 7171
Email
godarziz@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Godarzi
Position
Master of Science/Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, eastern Nosrat St, Tohid square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6692 7171
Email
godarziz@tums.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available