Determination the effect of self-control program on the quality of life of adolescents with diabetes
Design
A randomized clinical trial with a control group with pre and post test design, a blinded one with 56 adolescents with type 1 diabetes
Settings and conduct
Regarding the number of teenagers covered by the Janan Charity Association, sampling was used in an accessible manner,All files of patients were assigned a number, the file number and number were written on paper;The number and case number were written on paper and mixed in the dish. The first number that was randomly selected from all the numbers was in the test group and the next number in the control group until the end of the study.
Participants/Inclusion and exclusion criteria
Diabetes diagnosis for more than 1 year
;Do not have acute side effects;Willing to participate in the study; Do not participate in the same study at the same time;Unwillingness to continue cooperation in research
Intervention groups
Self-control training program was held for 6 sessions per week for two sessions and 3 weeks for the test group;After completing the questionnaire, the control group completed a training manual on type 1 diabetes at the end of the training sessions.
Main outcome variables
The general score of quality of life
The score of quality of life dimentions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181213041951N1
Registration date:2019-02-03, 1397/11/14
Registration timing:registered_while_recruiting
Last update:2019-02-03, 1397/11/14
Update count:0
Registration date
2019-02-03, 1397/11/14
Registrant information
Name
zinat mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7595
Email address
zinatmohammadi2016@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-30, 1397/11/10
Expected recruitment end date
2019-03-15, 1397/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of self–control program on quality of life in adolescents with Diabetic Type 1
Public title
"The Effectiveness of self–control on quality of life in adolescents diabetes"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year of diagnosis of diabetes have been past
Do not have acute side effects
Willing to participate in the study
Do not participate in the same study at the same time
Exclusion criteria:
Unwillingness to continue cooperation in research
Physical-psychological disabilities and other chronic disease
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
simple accident
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were unaware of the allocation of study groups
Placebo
Not used
Assignment
Factorial
Other design features
Sampling was done using available method and the samples were randomly assigned to two groups of intervention and control
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Associate Professor of Research & Technology, Ethics committee of Isfahan University of Medical Scie
Street address
Isfahan University of Medical Sciences, Faculty of Nursing and MidwiferyAzadi Square, Hezar- Jerib Ave.,
City
Isfehan
Province
Isfehan
Postal code
8174673465
Approval date
2018-10-03, 1397/07/11
Ethics committee reference number
230.IR.MUI.RESEARCH.REC.1397.
Health conditions studied
1
Description of health condition studied
quality of life
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Quality of Life Score in Quality of Life Questionnaire for Adolescents with Diabetes
Timepoint
Before and after training the program of self-control
Method of measurement
Quality of Life Questionnaire for Adolescents with Diabetes
2
Description
Score the dimensions of the quality of life
Timepoint
Before and after training the program of self-control
Method of measurement
Quality of Life Questionnaire for Adolescents with Diabetes
Secondary outcomes
empty
Intervention groups
1
Description
For the intervention group, self-control skills training classes were conducted in 6 sessions, twice a week, through slides, questions and answers, and lectures.
Category
Behavior
2
Description
Control group: after completing the final questionnaire, the educational pamphlet was given
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Janan Clinic
Full name of responsible person
Ayoub Shahpouri
Street address
No,16; Knowledge Ave; Shariati Ave: Najafabad Town
City
Isfahan
Province
Isfehan
Postal code
8513774791
Phone
+98 31 4246 0640
Fax
+98 31 4262 7006
Email
janan.ansar@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Deputy Director of Research and Technology
Street address
Hezar-Jerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zinat Mohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO, 16, Qods Ave, Shahid Azari, Najafabad Town
City
Isfahan
Province
Isfehan
Postal code
8517663661
Phone
+98 31 4274 8979
Email
zinatmohammadi2016@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Soheila Jafari-Mianaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Faculty of Nursing &Midwifery, Azadi Square, Hezarjereeb Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7595
Email
m_jafari@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zinat Mohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No,16, Qods Ave, Shahid Azari, Najafabad Town
City
Isfahan
Province
Isfehan
Postal code
8517663661
Phone
+98 31 4274 8979
Email
zinatmohammadi2016@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
This file is secret.
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
No - There is not 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
Protocol and data analysis will be published as an article
When the data will become available and for how long
After the finishing of research and publishing the article
To whom data/document is available
All the people that the result of the research is useful for them
Under which criteria data/document could be used
For increasing quality of life of diabetic teenagers
From where data/document is obtainable
Zinat Mohammadi
What processes are involved for a request to access data/document