The effect of peer education on self-care behaviors and mean of glycosylated hemoglobin in 12-18 year old adolescents with type 1 diabetes referring to Imam Reza(AS) Clinic in Shiraz, 2018
1- Determination and comparison of the mean score of self-care behaviors in the intervention and control groups before and 3 months after the intervention.
2- Comparison of mean score of self-care behaviors between two intervention and control groups before and 3 months after intervention
3- Determination and comparison of the mean of glycosylated hemoglobin in the intervention and control groups before and 3 months after the intervention.
4. Comparison of the mean of glycosylated hemoglobin between the two intervention and control groups before and 3 months after the intervention
Design
The clinical trial has a community-based, practice-oriented control group, with parallel groups, randomized, Random allocation of the samples in the intervention and control groups using the permutation block method
Settings and conduct
Referring to Imam Reza (AS) Clinic of Diabetes Shiraz, a simple, purposeful sampling among adolescents with type 1 diabetes who are eligible to enter the study
Participants/Inclusion and exclusion criteria
Entry Requirements:
1- Age 18-12 years
2- Confirmation of Type 1 Diabetes by a Specialist
3. Not having physical restrictions on self-care
4.Glycosylated hemoglobin levels greater than 7.5%
5- Having a medical record in the diabetes clinic
6. The history of diabetes for more than a year
7. Satisfaction of adolescents and their parents to participate in the study
Exit terms:
1. Unwillingness to continue participating in the study
2.Having mental illness prevents learning
3.Taking effective medications for learning and alertness
4. Case of other chronic diseases
Intervention groups
Four 90-minute class sessions organized by peers for the intervention group. while the control group receives routine training (educated by the clinic staff).
Main outcome variables
Mean of self-care behaviors ,Mean of glycosylated hemoglobin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180904040944N1
Registration date:2018-10-06, 1397/07/14
Registration timing:prospective
Last update:2018-10-06, 1397/07/14
Update count:0
Registration date
2018-10-06, 1397/07/14
Registrant information
Name
Afsaneh Zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4341 6127
Email address
stud2420430530@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-26, 1397/08/04
Expected recruitment end date
2018-11-15, 1397/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peer education on self-care behaviors and mean of glycosylated hemoglobin in 12-18 year old adolescents with type 1 diabetes referring to Imam Reza(AS) Clinic in Shiraz, 2018
Public title
Effect of peer education on self-care behaviors and mean of glycosylated hemoglobin in adolscents with type 1 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-12 years
Confirmation of type 1 diabetes by specialist physician
Not having physical restrictions on self-care
Glycosylated hemoglobin levels greater than 7.5%
Having a medical record in a diabetes clinic
The history of diabetes for more than a year
Satisfaction of adolescents and their parents to participate in the study
Exclusion criteria:
Unwillingness to continue participating in the study
Having mental illness prevents learning
Taking effective medications for learning and alertness
Cases of other chronic diseases
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the samples in the intervention and control groups, the permutation block method will be used and the randomization list will be based on randomization and random allocation and will be provided by the software for the two groups A and B, and the block sizes are quadruple and the numbers 1 and 6 will be reversed. Different will be assigned.
1.AABB
2.ABAB
3.ABBA
4.BBAA
5.BABA
6.BAAB
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 Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Avenue, Shiraz
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.SUMS.REC.1397.324
Health conditions studied
1
Description of health condition studied
Diabete
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
mean of glycosylated hemoglobin
Timepoint
At the beginning of the study and three months after the study
Method of measurement
The method of measuring glycosylated hemoglobin in this study is a calorimetric method using a Dirui auto-analyzer, which is calibrated daily.
2
Description
Mean score of self-care behaviors
Timepoint
At the beginning of the study and three months after the study
Method of measurement
Self-care questionnaire in adolescents with type 1 diabetes
Secondary outcomes
empty
Intervention groups
1
Description
After dividing the intervention group into 6 groups of 8, and assigning peers, each peer intervention group will be assigned a random number table. Peer-to-peer patients will be trained by their group on a weekly basis over 4 90-minute sessions. Face-to-face meetings will be grouped with questions and answers.
Category
Behavior
2
Description
Control group: The control group received routine training (training by the clinical staff).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza (AS) Clinic of diabetes in Shiraz
Full name of responsible person
Rezaie Attar
Street address
Namazi Square, Zand Avenue, Shiraz
City
شیرلز
Province
Fars
Postal code
7134814734
Phone
+98 71 3231 9362
Email
bonyaddiabet.az13@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyyed Basir Hashmi
Street address
Central Building of Shiraz University of Medical Sciences, Zand Avenue, Shiraz
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mitra Edraki
Position
Structor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery, University of Medical SciencesShiraz, Namazi Square, Zand Avenue, Shiraz
City
Shiraz
Province
Fars
Postal code
1985717443
Phone
+98 71 3647 4255
Email
edrakim@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mitra Edraki
Position
Structor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery, University of Medical SciencesShiraz, Namazi Square, Zand Avenue, Shiraz
City
Shiraz
Province
Fars
Postal code
1985717443
Phone
+98 71 3647 4255
Email
edrakim@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mitra Edraki
Position
Structor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery, University of Medical SciencesShiraz, Namazi Square, Zand Avenue, Shiraz
City
Shiraz
Province
Fars
Postal code
1985717443
Phone
+98 71 3647 4255
Email
edrakim@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions, people working in the industry
Under which criteria data/document could be used
Any copying is grateful.
Observance of the principles of compilation is obligatory.
From where data/document is obtainable
Referring to the academic staff member, Ms. Mitra Edraki
address to School of Nursing Midwifery, University of Medical Sciences Shiraz, Namazi Square, Zand Avenue, Shiraz
Contact with Academic Officer Mrs. Mitra Edraki
contact person: 0098 9177008428
By email: edrakim@sums.ac.ir
What processes are involved for a request to access data/document
Applicants requesting the use of documents and data files can be contacted by email or by contact or by referring to the academic officer. The listing of the hive can be obtained by email in PDF format five days after the application is submitted.