Evaluating the effect of blended eductional intervention on blood pressure among type 2 diabetic patients with hypertension referred to health care setting of south of Tehran in 2013-2014: Application of BAZNEF Model
This study is a semi experimental intervention with control group. Study populations are type 2 diabetic patients with hypertension referred to health centers of South of Tehran. The instrument of this study comprises the questionnaire designed based on BAZNEF Model including demographic information and BAZNEF Model constructs and clinical characteristics of type2 diabetes patients with hypertension. In this study, blended educational intervention will be conducted after pretest, anthropometric variables and blood pressure for intervention group. After six months, the questionnaire and clinical examination recompleted. After tests, SPSS software version 11.5 will be used in order to statistical analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013062312460N2
Registration date:2013-06-29, 1392/04/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-29, 1392/04/08
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
Educational and Research vice chancellor of Tehran University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of blended eductional intervention on blood pressure among type 2 diabetic patients with hypertension referred to health care setting of south of Tehran in 2013-2014: Application of BAZNEF Model
Public title
Evaluating the effect of blended eductional intervention on blood pressure among type 2 diabetic patients with hypertension referred to health care setting of south of Tehran in 2013-2014: Application of BAZNEF Model
Purpose
Other
Inclusion/Exclusion criteria
Confirming of type 2 diabetes and hypertension for at least one year (By specialist physician) , confirming blood pressure at least 130/80 mmHg and 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:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Public Health, Tehran University of Medical Sciences
Street address
Poursina Ave.
City
Tehran
Postal code
Approval date
2013-06-22, 1392/04/01
Ethics committee reference number
22745
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
I10-15
ICD-10 code description
Type 2 diabetes
2
Description of health condition studied
Hypertension
ICD-10 code
E10-14
ICD-10 code description
Hypertension
Primary outcomes
1
Description
Hypertension
Timepoint
Baseline and six months later
Method of measurement
Stigno monometer
2
Description
BAZNEF Model constructs
Timepoint
Baseline and six months later
Method of measurement
Questionnair
Secondary outcomes
1
Description
Hypertension
Timepoint
Baseline and six months later
Method of measurement
Stigno monometer
2
Description
BAZNEF Model constructs
Timepoint
Baseline and six months later
Method of measurement
Questionnaire
3
Description
Knowledge
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 hypertension, consequences of hypertension with on type 2 diabetic patients and types of cardiovascular complications, blood pressure control methods and 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
South of Tehran Health centers
Full name of responsible person
Street address
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
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
2
Sponsor
Name of organization / entity
Research vice chancellor of Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotohi
Street address
Main buildingof 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
Research vice chancellor of Tehran University of Medical Sciences
Proportion provided by this source
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
141556446
Phone
+98 21 4293 3210
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
141556446
Phone
+98 21 4293 3210
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
141556446
Phone
+98 21 4293 3210
Fax
+98 42933072
Email
sadeghir@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)