The purpose of this study was to determine the effect of educational intervention based on sociological cognitive theory on self-care behaviors in type 2 diabetes patients in Mashhad
Design
60 Patients with diabetes will be selected based on inclusion and exclusion. 30 Patients will be in the intervention group and 30 Patients will be in the control group
Settings and conduct
An educational intervention in the intervention group will be conducted for a maximum of one month, with emphasis on the influential structures of the theory by using educational strategy
Participants/Inclusion and exclusion criteria
Having Type II Diabetes, Satisfaction to participate in the study
Intervention groups
Intervention group:educational intervention for a maximum of one month, with emphasis on the influential structures of the theory by using educational strategy
Control group: No intervention
Main outcome variables
Self-care behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160619028529N6
Registration date:2018-01-12, 1396/10/22
Registration timing:retrospective
Last update:2018-01-12, 1396/10/22
Update count:0
Registration date
2018-01-12, 1396/10/22
Registrant information
Name
Hadi Tehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3853 8530
Email address
tehranih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-09-16, 1395/06/26
Expected recruitment end date
2017-10-17, 1396/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based social cognitive theory on self- care behavior of type 2 diabetes
Public title
The effect of education on diabetes self care
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having Type II Diabetes
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
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 Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Qoreishi Building, Daneshgah 18, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2016-08-05, 1395/05/15
Ethics committee reference number
IR.MUMS.REC.1395.155
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Diabetes Self Care
Timepoint
Before intervention،Immediately and 3 months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Construct of Social Cognitive Theory
Timepoint
Before intervention،Immediately and 3 months after the interventio
Method of measurement
Questionnaire
Intervention groups
1
Description
The intervention group received educational content based on effective structures of social cognitive theory. Educational content based on predetermined objectives presented in 4 sessions(90 minutes)
Category
Behavior
2
Description
Control group: No intervention was done for control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hasan Mojtaba Health Center
Full name of responsible person
Mastoreh sadat Ghoreishi
Street address
Alley 73, Hijat St., Qasem Abad,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Fax
+98 51 3854 1514
Email
mastoreh58@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice President of Research, Qoreishi Building, Daneshgah 18, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 3007
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, Between 16th and 18th Daneshgah, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 4633
Fax
Email
Tehranih@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, between 16th and 18th Daneshgah, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 4633
Fax
Email
Tehrenih@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, between 16th and 18th Daneshgah, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 4633
Fax
Email
Tehranih@muma.ac.ir
Web page address
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
Potential data is sharable after distinguishing people
When the data will become available and for how long
Start the access period one month after the publication of result
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data is sent through an official request and by email
From where data/document is obtainable
Hadi Tehrani tehranih@mums.ac.ir
What processes are involved for a request to access data/document
Data is sent through an official request and by email