Investigating the effect of educational program to improving health literacy based on Bandura's learning-cognitive theory on self-efficacy and social anxiety in adolescents with type 1 diabetes.
Determining the effect of health literacy promotion training program based on Bandura social-learning theory on self-efficacy and social anxiety of adolescents with type 1 diabetes
Design
The present quasi-experimental study with intervention and control group, without blinding, randomized on 60 adolescents with type 1 diabetes, was performed using the Rand function of Excel software.
Settings and conduct
The present study is a quasi-experimental study. It has two groups of intervention and control. Adolescents with inclusion criteria were admitted to the endocrine clinic of the Children's Medical Center and the endocrine clinic of the Mofid Children's Hospital. Oral and written consent was obtained from the adolescent and their parents. Before the start of the training sessions, the pre-test was completed by the researcher in the form of a telephone interview. After the necessary coordination, the trainings were held in the form of games and virtually. One month later, the post-test was completed by telephone by the researcher.
Participants/Inclusion and exclusion criteria
- Admission criteria:
Age range 15-18years
Willingness to participate in the study
Native to Tehran
Literate
Ability to talk and communicate
- Exclusion criteria:
Passing the Diabetes Health Literacy course
Acute and debilitating complications of the disease
Having a mental illness
Intervention groups
Intervention group: During 4 training sessions of 60 to 90 minutes, a health literacy promotion program based on social learning theory will be implemented.
- Control group: In this group, no intervention will be done.
Main outcome variables
Health literacy in diabetes; Social anxiety; Self-efficacy; The incidence of complications of diabetes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210422051045N1
Registration date:2022-01-28, 1400/11/08
Registration timing:retrospective
Last update:2022-01-28, 1400/11/08
Update count:0
Registration date
2022-01-28, 1400/11/08
Registrant information
Name
vida Rahimi hassanabad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 3165
Email address
vida.rahimi13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of educational program to improving health literacy based on Bandura's learning-cognitive theory on self-efficacy and social anxiety in adolescents with type 1 diabetes.
Public title
Investigating the effect of improving diabetes health literacy on self-efficacy and social anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 15-18 years
Willingness to participate in the study
Confirmation of type 1 diabetes by an endocrinologist
Literate
Has the ability to talk and communicate
Native to Tehran
Exclusion criteria:
Acute and debilitating complications of the disease
Having a chronic illness other than diabetes
Having a mental illness
Age
From 15 years old to 18 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
Simple randomization. In this method, the name of each of the adolescents with type 1 diabetes in each group is poured into a ball separately, and finally the members of each group are determined completely randomly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, health literacy constructs based on the Bandura's social learning theory will be taught.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
School of Nursing and Midwifery Tehran University of Medical Sciences, Mirkhani Street, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-05-27, 1399/03/07
Ethics committee reference number
IR.TUMS.FNM.REC.1399.038
Health conditions studied
1
Description of health condition studied
Type 1 Diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Health literacy score in the health literacy questionnaire of adolescents with diabetes
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Health Literacy Questionnaire for Adolescents with Diabetes
2
Description
Functional self-efficacy score in the Diabetes Functional Self-efficacy Questionnaire
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Functional self-efficacy questionnaire in diabetes
3
Description
Social Anxiety Score in Paklak Adolescent Social Anxiety Questionnaire
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Paklak Social Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: The present study is a quasi-experimental study and has an intervention group of 30 adolescents with type 1 diabetes who meet the inclusion criteria. The content of the training, scenarios and games designed by 10 professors, psychologists and pediatric endocrinologists and subspecialists will be validated using authoritative scientific sources and during 4 consecutive training sessions for 4 days for 60 to 90 minutes using Learning methods of lectures, questions and answers, role play, games, use of pictures and educational clips (based on Bandura's social learning theory) will be held completely virtually through Skyroom. The first to fourth sessions will be related to nutrition, exercise, insulin therapy, blood sugar self-monitoring and follow-up, respectively.
Category
Behavior
2
Description
Control group: The present study is a quasi-experimental study and has a control group of 30 adolescents with type 1 diabetes who meet the inclusion criteria. Before performing the intervention, a pre-test was taken from the control group at the same time as the intervention group. There was no intervention in this group. One month after the intervention in the intervention group, a post-test was taken from this group at the same time as the intervention group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid pediatric endocrinology and diabetes clinic
Full name of responsible person
Dr. Hedieh Saneifard
Street address
Mofid Children's Hospital, Dr. Ali Shariati St.
City
Tehran
Province
Tehran
Postal code
15514- 15468
Phone
+98 21 2222 7212
Fax
+98 21 2222 0254
Email
vida.rahimi13@yahoo.com
Web page address
https://mch.sbmu.ac.ir/
2
Recruitment center
Name of recruitment center
Children's Medical Center Hospital
Full name of responsible person
Dr. Aria Sotoudeh
Street address
No. 62, Children's Medical Center Hospital, Dr. Gharib St., at the end of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2266
Fax
+98 21 6693 0024
Email
cmcpr@tums.ac.ir
Web page address
https://chmc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Geranmayeh
Street address
No. 62, School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani St., Tohid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fnm-researchdeputy@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
Vida Rahimi hassanabad
Position
Master of pediatric nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 62, School of Nursing and Midwifery Tehran University of Medical Sciences, Mirkhani St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
vida.rahimi13@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Jamaladin Begjani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 62, School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6693 7120
Email
jamalbegjani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vida Rahimi hassanabad
Position
Master of Pediatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 62, School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
vida.rahimi13@yahoo.com
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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After identifying the individuals, the overall results will be published in a file format.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Research subjects and research team
Under which criteria data/document could be used
No other analysis is allowed by people other than the research team.
From where data/document is obtainable
Contact with project manager: Vida Rahimi Hassanabad
09229832590
What processes are involved for a request to access data/document