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Comparison of the Effect of Educational Intervention based on Web and Manual on Mammography Use in Women: An Application of Health Belief Model

Protocol summary

Study aim
Comparison of the Effect of Educational Intervention based on Web and Manual on Mammography Use in Women Covered by Bushehr Health Services Centers: An Application of Health Belief Mode
Design
Semi-experimental study; It has two intervention groups and one control group; random sampling; With parallel groups; The sample size is 126 women aged 40 years and older.
Settings and conduct
The study is carried out at Bushehr Health Care Centers, 2 centers are as an intervention group and 1 center as control group. Blinding is impossible but to avoid interruptions in the study (information bias between groups) the centers selected as an intervention group are separate from the control group.
Participants/Inclusion and exclusion criteria
Information recorded in Health Care centers,Having reading and writing skills & the ability to communicate verbally,Age 40 and over,Suitable physical conditions to answer questions and participate in the study, having access to the internet and the knowledge to use it,Having computer and smartphone ,Inclination to participate in the research,Failure to do mammograms in the last two years,Having breast cancer,Pregnancy,Lactation,Having chest disease history,A history of breast cancer in a first degree family,Drop out of the study
Intervention groups
One intervention group will view the Health Belief model-based education program for one week. Additionally, from the interval between the completion of the education program till two weeks later, Reminder messages will be sent once a week to persuade learners to view the educational content uploaded on the website. The next intervention group will receive a booklet. The control group will receive routine care. The assessment will be done by the questionnaire, before intervention, and two months after the intervention.
Main outcome variables
Awareness, Barriers, Benefits, Susceptibility, Severity,Health Motivation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190708044157N1
Registration date: 2019-08-09, 1398/05/18
Registration timing: prospective

Last update: 2019-08-09, 1398/05/18
Update count: 0
Registration date
2019-08-09, 1398/05/18
Registrant information
Name
Zeynab Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3344 1695
Email address
z.mansoori@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-21, 1398/05/30
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Educational Intervention based on Web and Manual on Mammography Use in Women: An Application of Health Belief Model
Public title
The effect of the training program on mammography behavior
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Information recorded in Health Care centers Having reading and writing skills & the ability to communicate verbally Age 40 and over Suitable physical conditions to answer questions and participate in the study having access to the internet and the knowledge to use it Having computer and smartphone Inclination to participate in the research Failure to do mammograms in the last two years
Exclusion criteria:
Having breast cancer Pregnancy Lactation Having chest disease history A history of breast cancer in a first degree family Drop out of the study
Age
From 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
From all the centers, three are selected via simple random sampling, one center as a web-based intervention group and one center as an intervention group receiving booklet and one center as a control group. In the next step, based on the electronic file in the SIB system individuals having inclusion criteria matches the study sample size are selected randomly.
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 Bushehr University of Medical Sciences
Street address
. Boushehr University of medical sciences and health services,Salman Farsi St.Bahmani,Bushehr ,
City
Bushehr
Province
Boushehr
Postal code
7556194917
Approval date
2019-07-24, 1398/05/02
Ethics committee reference number
IR.BPUMS.REC.1398.087

Health conditions studied

1

Description of health condition studied
Breast cancer screening
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Breast cancer screening behavior
Timepoint
Before intervention and two months after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Awareness
Timepoint
Before intervention and two months after intervention
Method of measurement
Questionnaire

2

Description
Perceived Benefits
Timepoint
Before intervention and two months after intervention
Method of measurement
Questionnaire

3

Description
Perceived Barriers
Timepoint
Before intervention and two months after intervention
Method of measurement
Questionnaire

4

Description
Perceived Susceptibility
Timepoint
Before intervention and two months after intervention
Method of measurement
Questionnaire

5

Description
Perceived Severity
Timepoint
Before intervention and two months after intervention
Method of measurement
Questionnaire

6

Description
Health Motivation
Timepoint
Before intervention and two months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: After extracting the names of women aged 40 years and over, the electronic records are reviewed to evaluate some of the criteria for entering the study. For the web-based model-based intervention group there is a description of how to access and use the content of the educational content, including: videos, images and educational texts (multimedia) through the site to individuals. The multimedia educational content is based on the health belief model. The educational package is uploaded to the website after compilation and individuals are asked to view the instructions within a maximum of 1 week. After three days the individuals who have not yet visited the website are contacted and encouraged to use the site's content. And for the individuals who have not yet seen the content of the instructions, the will be given an additional three days to receive the instructions. For the intervention groups in the first month, two reminder messages will be sent within two weeks by SMS. Before and up to two months after the training program, the questionnaires will be completed for each of the three groups.
Category
Prevention

2

Description
Intervention group: After extracting the names of women aged 40 years and over, the electronic records are reviewed to evaluate some of the criteria for entering the study. For the intervention group, the (educational) content will be model-based and in the form of a booklet. Before and up to two months after the training program, the questionnaires will be completed for each of the three groups.
Category
Prevention

3

Description
Control group: Get routine care. At the end of the training program, the control group will be provided with the educational content.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada health care center
Full name of responsible person
Zahra Hozhbari
Street address
Shohada health care center,Behesht Sadegh St.Boushehr,
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3334 0547
Fax
Email
Hojabri.a@gmail.com
Web page address

2

Recruitment center
Name of recruitment center
Shahid Beheshti health care center
Full name of responsible person
Katayoun Alibashi
Street address
Shahid Beheshti health care center,Khajeh Ha,Boushehr
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3344 0547
Fax
Email
Alibashi.k@gmail.com
Web page address

3

Recruitment center
Name of recruitment center
Hazrat Zainab health care center
Full name of responsible person
Farzaneh Agha
Street address
Hazrat Zainab health care center ,end of E'temadiyeh St. Davvas,Boushehr
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3344 0805
Email
f.agha@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamesipour
Street address
Boushehr University of medical sciences and health services,Salman Farsi St.Bahmani, Boushehr
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
khamisipoor@Bpums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Hemameddin Javadzade
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
. Boushehr University of medical sciences and health services,Salman Farsi St.Bahmani, Boushehr
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 0084
Email
sh.javadzadeh@bpums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Hemameddin Javadzade
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Boushehr University of medical sciences and health services,Salman Farsi St.Bahmani, Boushehr
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 0084
Email
sh.javadzadeh@bpums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Zeynab Mansouri
Position
Masters student of health education and health promotion
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Boushehr University of medical sciences and health services,Salman Farsi St.Bahmani, Boushehr
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 33441695
Email
Zeynabmansouri96@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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