Protocol summary

Summary
The purpose of this study is to evaluate the effect of educational package that is based on health belief model and is prepared for people at risk of cardiovascular diseases who referred to Khatamolanbiae clinic to modify unhealthy behaviors. 100 patients will be enrolled in this randomized clinical trial.Main inclusion criteria is having at least one risk factor of cardiovascular disease and main exclusion criteria is being illiterate. After collecting questionnares, patients will be divided into 2 groups randomly (intervention group and control group). Then educational package will be given to intervention group. After 2 months we will collect questionnaires from both groups and data will be analyzed. Primary outcome measure is preventive behaviors. Primary outcome measure is preventive behaviors.

General information

Acronym
Health Belief Model
IRCT registration information
IRCT registration number: IRCT201201238803N1
Registration date: 2012-09-29, 1391/07/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-09-29, 1391/07/08
Registrant information
Name
Tahereh Rahimdel
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3726 6711
Email address
rahimdel@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Shahid Sadoughi University of Medical Sciences.Dr Mohamad hasan Ehrampoush
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2011-08-11, 1390/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational Package Based on Health Belief Model for People at Risk of Cardiovascular Disease to Modify Unhealthy Behaviors.
Public title
Effect of Educational Package on Doing Preventive Behaviors of Cardiovascular disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:30-65 years old; having at least one Risk Factor of Cardiovascular Disease; Free of Diagnosed Heart Disease & Free of Mental Disorders exclusion criteria : Being Illiterate; Unable to read
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Shahid Sadoughi University of Medical Sciences
Street address
Deputy Research ;Central Building of Medical University; Bahonar square.
City
Yazd
Postal code
8916978477
Approval date
2011-06-04, 1390/03/14
Ethics committee reference number
29612

Health conditions studied

1

Description of health condition studied
Acude myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acude myocardial infarction

2

Description of health condition studied
Subsequent myocardial infarction
ICD-10 code
I22
ICD-10 code description
Subsequent myocardial infarction

3

Description of health condition studied
Certain current complications following acute
ICD-10 code
I23
ICD-10 code description
Certain current complications following acute myocardial infarction

4

Description of health condition studied
Other acute ischaemic heart diseases
ICD-10 code
I24
ICD-10 code description
Other acute ischaemic heart diseases

5

Description of health condition studied
Chronic ischaemic heart disease
ICD-10 code
I25
ICD-10 code description
Chronic ischaemic heart disease

6

Description of health condition studied
Angina pectoris
ICD-10 code
I20
ICD-10 code description
Angina pectoris

Primary outcomes

1

Description
Preventive behaviors
Timepoint
At first of study and 2 months after intervention
Method of measurement
Questionare

Secondary outcomes

1

Description
Knowledge
Timepoint
At the first of study & 2 months after intervention
Method of measurement
Questionnare

2

Description
Perceived susceptibility
Timepoint
At first of study $ 2 months after intervention
Method of measurement
Questionnare

3

Description
Perceived severity
Timepoint
At first of study & 2 montha after intervention
Method of measurement
Questionnare

4

Description
Perceived benefits
Timepoint
At first of study & 2 months after intervention
Method of measurement
Questionnare

5

Description
Perceived barriers
Timepoint
At first of study & 2 months after intervention
Method of measurement
Questionnare

6

Description
Self efficacy
Timepoint
At first of study & 2 months after intervention
Method of measurement
Questionnare

7

Description
Cues to action
Timepoint
At first of study & 2 months after intervention
Method of measurement
Questionnare

Intervention groups

1

Description
Intervention Group Will Receive Educational Package (5 Educational Booklets)
Category
Prevention

2

Description
Control Group Are Expose Usual Educations(Mass Media,..)
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Khatamolanbiae Clinic
Full name of responsible person
Tahereh Rahimdel
Street address
Taleghani blv,next to the central libratory
City
yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr.Mohamad Hasan Ehrampoush
Street address
Iman Reza Resaech & Educational Complex
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
shahid sadoughi university of medical sciences
Full name of responsible person
tahereh rahimdel
Position
research expert/BSc
Other areas of specialty/work
Street address
shahid sadoughi deputy research
City
yazd
Postal code
Phone
+98 35 1726 6711
Fax
+98 72 58413
Email
rahimdell@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hossein Baghianimoghadam
Position
phD -Health Education
Other areas of specialty/work
Street address
Daneshjo blv/Imam Reza Research & Educational
City
Yazd
Postal code
Phone
+98 35 1623 8626
Fax
Email
baghianimoghadam@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Tahereh Rahimdel
Position
Research Expert/Public Health BA
Other areas of specialty/work
Street address
Deputy Research; rCentral Building of University;Bahonar Sq.
City
yazd
Postal code
8916978477
Phone
+98 35 1726 6711
Fax
+98 72 58413
Email
rahimdel2000@yahoo.com
Web page address
rahimdel@ssu.ac.ir

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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