Protocol summary

Study aim
Determining the effect of educational intervention based on PRECEDE-PROCEED model in the prevention of brucellosis and livestock vaccination process in Lighwan village, East Azarbaijan province.
Design
Single blind clinical trial with control group
Settings and conduct
Training on brucellosis disease in the village of Lighvan, Tabriz
Participants/Inclusion and exclusion criteria
The criteria for the study include accommodation in the area and activity in livestock breeding; consenting to participate in the study and the absence of a history of brucellosis and receiving related training in this field in the past. Exit criteria include the inability to use the educational package intended for this study; including physical disabilities; including visual and auditory problems; limitation and absenteeism in more than 20% of the training sessions which can provide learners with the required level of learning; noticeable attention.
Intervention groups
Model-based intervention in ranchers
Main outcome variables
Reduction of brucellosis and increased brucellosis vaccination

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180304038945N1
Registration date: 2018-12-24, 1397/10/03
Registration timing: registered_while_recruiting

Last update: 2018-12-24, 1397/10/03
Update count: 0
Registration date
2018-12-24, 1397/10/03
Registrant information
Name
farhad bahadori
Name of organization / entity
Tarbeat modares
Country
Iran (Islamic Republic of)
Phone
+98 41 3331 9028
Email address
f.bahadori@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of a theory-based educational intervention on the prevention of brucellosis and livestock vaccination process
Public title
Determining the effect of a theory-based educational intervention on the prevention of brucellosis and livestock vaccination process
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Livestock in Lighvan village Residence in the area and activities in the livestock sector Declaring consent to participate in the study Not having a history of brucellosis and receiving related training in this field in the past
Exclusion criteria:
The inability to use the educational package intended for this study, including physical inability, includes visual and auditory problems Limitation and absenteeism in more than 20% of the training sessions that can significantly affect learners' learning
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Random software
Blinding (investigator's opinion)
Single blinded
Blinding description
The target group is the same stockbreeder
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Jalal Al-e Ahmad
City
tehran
Province
Tehran
Postal code
14115-111
Approval date
2018-05-16, 1397/02/26
Ethics committee reference number
IR.MODARES.REC.1397.001

Health conditions studied

1

Description of health condition studied
Brucellosis
ICD-10 code
A23.0
ICD-10 code description
Brucellosis due to Brucella melitensis

Primary outcomes

1

Description
Average scores of predisposing factors
Timepoint
Before the intervention, immediately after the intervention and 2 months after it
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Brucella antibody level in sheep
Timepoint
Before and after the vaccination season
Method of measurement
ELISA test or Rozbangal

Intervention groups

1

Description
Intervention group: Farmers' behavior in vaccination against brucellosis and preventive behaviors. To do this, the intervention training is tailored to the target group for at least four sessions for an hour through the methods of the front line or using textual methods including brochures, etc.
Category
Behavior

2

Description
Control group: The non-intervention control group and routine training will be given annually. Finally, after training, the effect of education was assessed in two intervention and control groups
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Lighvan village( individual livestocks)
Full name of responsible person
Fazlollah Ghofranipour
Street address
lighvan village- Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
12345
Phone
+98 21 8288 0000
Email
ghoranipourf@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat modares
Full name of responsible person
Fazlollah Ghofranipour
Street address
jalale al ahmad
City
tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3869
Email
ghofranif@modares.ac.ir
Grant name
Research Deputy of Tarbiat Modares University
Grant code / Reference number
1410827
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat modares
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
Tarbiat modares
Full name of responsible person
Fazlollah Ghofranipour
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
jalale al ahmad
City
tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3869
Fax
+98 21 8288 3869
Email
ghofranf@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat modares
Full name of responsible person
Fazlollah Ghofranipour
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal AleAhmad
City
tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3869
Email
ghofranf@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat modares
Full name of responsible person
Fazlollah Ghofranipour
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal AleAhmad
City
tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3869
Email
ghofranf@modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as the original outcome information, will be available
When the data will become available and for how long
Two years after the start of the project and in 2019 inwards
To whom data/document is available
University researchers-veterinarians- and veterinarians related to the livestock industry
Under which criteria data/document could be used
Governmental centers with official permissions from relevant departments
From where data/document is obtainable
Contact by e-mail and phone number with Dr. Fazlollah Ghofranipour Ers-Tehran Jalal Al-Ahmad Tarbiat Modares University ghofranipourf@gmail.com 00982182880
What processes are involved for a request to access data/document
Contact via emailCommunication via email and phone - if applicable, within a week to one month
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