Protocol summary

Summary
This study aimed at assessing the effect of educational intervention based on BAZNEF Model on some barriers of living with diabetes among diabetic patients. Inclusion criteria were at least one year after confirmation of diagnosis and satisfaction of participation in the study. Study population was type 2 diabetic patients referred to health centers of South of Tehran and 90 patients selected randomly. In this study, educational intervention based on BAZNEF Model conducted in six educational sessions 60-45 minutes after pretest for intervention group during one month. Primary outcome of current study was decreasing barriers of living with diabetes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015010712460N3
Registration date: 2015-02-02, 1393/11/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-02, 1393/11/13
Registrant information
Name
Roya Sadedgi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 327 5692
Email address
sadeghir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Education vice chancellor of Tehran University of Medical Sciences
Expected recruitment start date
2015-01-13, 1393/10/23
Expected recruitment end date
2015-06-03, 1394/03/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of educational intervention on some barriers of living with diabetes among type 2 diabetes: Application of BAZNEF Model
Public title
Assessing the effect of educational intervention on some barriers of living with diabetes among type 2 diabetes: Application of BAZNEF Model
Purpose
Prevention
Inclusion/Exclusion criteria
Confirming of type 2 diabetes for at least one year (By specialist physician) , consented to participate in the study .
Age
From 30 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Not randomized
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 commitee of Tehran University of Medical Sciences
Street address
Main Biulding of Tehran University of Medical sciences
City
Tehran
Postal code
Approval date
2014-09-04, 1393/06/13
Ethics committee reference number
93/د/130/ 1728

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
I10-15
ICD-10 code description
Type 2 diabetes

Primary outcomes

1

Description
BAZNEF Model constructs
Timepoint
Baseline and six months later
Method of measurement
Questionnaire

Secondary outcomes

1

Description
barriers in living with type 2 diabetes
Timepoint
Baseline and six months later
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention program will be conducted during one month including six educational sessions based on blended educational intervention program (Lecture, Group discussion, Question & Answer, Role playing, Educational film). The length of each session is about 55-60 minutes. In these sessions try to discuss about type 2 diabetes and living with diabetes , healthy diet. Family of patients will be participated in one of the educational sessions.
Category
Prevention

2

Description
In control group, education will be conducted based on routine plan of health centers.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Farmanfarmaian Health Center
Full name of responsible person
Fatemeh Ramezan Nejad
Street address
Opposite Melli Bank,Azarbayejan St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Education vice chancellor of Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohamad Jalili
Street address
Main Biulding of Tehran University of Medical sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Education vice chancellor of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Position
Academic staff
Other areas of specialty/work
Street address
School of Public Health, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8859 9888
Fax
Email
sadeghir@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Position
PhD
Other areas of specialty/work
Street address
School of Public Health, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 85 99888
Fax
Email
sadeghir@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roya Sadeghi
Position
PhD
Other areas of specialty/work
Street address
School of Public Health, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8859 9888
Fax
+98 21 8898 9129
Email
sadeghir@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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