Protocol summary

Study aim
determine the effects of interventions to reduce the risk of exposure to dust phenomenon based on protection motivation theory in cardiovascular disease patients
Design
Randomised controlled trial, with parallel groups and Community based. Sample size included 140 patients
Settings and conduct
From 23 health centers in Ahvaz, selecting 4 center, then from existing list of confirmed Cardiovascular disease patients, 140 patients willing to participate, will be recruited. 2 Center for the intervention group and 2 as the control group. The pre-test will be carried out after the allocation of groups. Then the interventions will be done, and post-test will be carried out 2 months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: have the desire to participate in the study, have cardiovascular disease, residents of Ahvaz, no physical disability and no psychological disorder, no deaf and blindness, ability to attend training sessions. Exclusion criteria: Residence less than 6 months in Ahvaz, Age less than 30 years.
Intervention groups
The intervention will be done in 2 groups: 1) Intervention group n = 70; The intervention consists of three consecutive one-hour sessions, and the educational program will be conducted using appropriate methods based on protection motivation theory and educational needs obtained during the sessions. Also, pamphlets and SMS messages are sent to individuals according to the conditions and during the intervention period. 2) Control group n = 70; No educational program will be implemented.
Main outcome variables
Behavior of risk reduction exposure to dust phenomena

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181127041775N1
Registration date: 2019-04-02, 1398/01/13
Registration timing: retrospective

Last update: 2019-04-02, 1398/01/13
Update count: 0
Registration date
2019-04-02, 1398/01/13
Registrant information
Name
Mehdi Mojadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3149 2178
Email address
mehdi.8984@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-08, 1397/09/17
Expected recruitment end date
2019-03-08, 1397/12/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing, Implementing and Evaluating of interventional programs Based on Protection Motivation Theory on dust phenomenon exposure risk reduction on Cardiovascular disease patients: a Mix method approach
Public title
Designing, Implementing and Evaluating of interventional programs on dust phenomenon exposure risk reduction on Cardiovascular disease patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have the desire to participate in the study. Have cardiovascular disease. They are residents of Ahvaz. There is no physical disability and no psychological disorder. Have low hearing and hearing impairment or low vision and blindness. Ability to attend training sessions.
Exclusion criteria:
Residence less than 6 months in Ahvaz Age less than 30 years
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
From 23 health centers, selecting 4 center (2 intervention center and 2 control center), then from a list of Cardiovascular disease patients confirmed, 140 patients willing to participate , will be recruited through simple random sampling using /https://www.randomizer.org.
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 Yazd Shahid Sadoughi University of Medical Sciences
Street address
School of Public Health, Shahid Sadoughi University of Medical Sciences, Safaiyeh, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2017-05-30, 1396/03/09
Ethics committee reference number
IR.SSU.SPH.REC.1396.36

Health conditions studied

1

Description of health condition studied
Dust phenomenon
ICD-10 code
X37.3
ICD-10 code description
Dust storm

Primary outcomes

1

Description
Behavior of risk reduction exposure to dust phenomena
Timepoint
Assessing the behavior of reducing the risk of exposure to dusts in the beginning of the study (before the intervention) and 60 days after the intervention.
Method of measurement
Reducing exposure to dust questionnaire , based on motivation protection theory

Secondary outcomes

1

Description
Protection Motivation (Intention) of risk reduction exposure to dust phenomena
Timepoint
Assessing the Protection Motivation (Intention) of reducing the risk of exposure to dusts in the beginning of the study (before the intervention) and 60 days after the intervention.
Method of measurement
Reducing exposure to dust phenomena questionnaire , based on motivation protection theory

Intervention groups

1

Description
Intervention group: the educational program will be conducted using appropriate methods based on protection motivation theory and educational needs obtained during the sessions. The interventions include 3 one hour sessions in 3 consequent days, with distribution of pamphlet and sending the SMS message. Educational sessions include: Objectives, Introduce the risk factors and the effects of dust on health, Perform self-care and preventative behaviors from dust exposure.
Category
Prevention

2

Description
Control group: No educational program will be implemented.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz west health center
Full name of responsible person
Mehdi Mojadam
Street address
15 West Street, Kianabad Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3391 4222
Fax
+98 61 3391 4227
Email
info@ajums.ac.ir
Web page address
http://hn-wah.ajums.ac.ir/HomePage.aspx?TabID=5720&Site=hn-wah.ajums.ac&Lang=fa-IR

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Shahid Sadoughi University of Medical Sciences, Safaiyeh, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3724 0171
Fax
+98 35 3724 0371
Email
mmirzaei@ssu.ac.ir
Web page address
http://ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mehdi Mojadam
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
School of Public Health, ShahidSadoughi University of Medical Sciences, Safaiyeh, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2178
Fax
Email
mehdi.8984@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Hasan Ehrampoush
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Environmental Health
Street address
School of Public Health, ShahidSadoughi University of Medical Sciences, Safaiyeh, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 983538209131
Email
ehrampoush@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mehdi Mojadam
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
School of Public Health, ShahidSadoughi University of Medical Sciences, Safaiyeh, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2178
Fax
Email
mehdi.8984@yahoo.com

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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