The randomized controlled trial comparing effectiveness of educational comprehensive plan based on Precede-Proceed model for prevention and control of Brucellosis among rural population.
The study will aim to investigate effectiveness of educational intervention based on Precede-Proceed model for control and prevention of Brucellosis in Ahar;Tabriz. The participants including people with 15 years old and over that recruit to study through health houses from stratified randomized sampling. Ahar county have four area (north, south, east and west) that two health centers of each area (control and intervention) and a health houses of each health centers will selected in rural with high prevalence of Brucellosis. After that the selected rural randomly will placed in control and intervention groups (n=200 per arm). Participants randomly will select from household health records. Then, head of household or his/her substitutions who have consent to participate in the study will recruited to the study. The pre test will conducted using questionnaires including General Health questionnaire 12, Short Form 12 quality of life and the Brucellosis Precede Proceed prevention model. The intervention will be planned by a Precede Proceed prevention model on brucellosis based on pre test results. Post test will carry out after six month of the intervention. The control group will receive educational program after the study. Primary outcome will include prevalence of Brucellsis and secondary outcomes will include self efficacy, social environment, reinforcing factors, knowledge, attitudes and behaviours related to brucellosis and general health and quality of life.
General information
Acronym
Brucellosis
IRCT registration information
IRCT registration number:IRCT201511078132N3
Registration date:2016-02-11, 1394/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-11, 1394/11/22
Registrant information
Name
Leila Jahangiry
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 307 0128
Email address
jahangiry@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2015-12-11, 1394/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The randomized controlled trial comparing effectiveness of educational comprehensive plan based on Precede-Proceed model for prevention and control of Brucellosis among rural population.
Public title
The Arasbaran comperhensive Brucellosis study
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterial: rural people living in Ahar county who have 15 and over years old;
the consent to participate in the study.
Exclusion criteria: Health center employee
Age
From 15 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Closed envelope was used for randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street, Azadi Steet, Tabriz
City
Tabriz
Postal code
Approval date
2015-10-15, 1394/07/23
Ethics committee reference number
TBZMED.REC.1394.596.
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
A23
ICD-10 code description
Brucellosis
Primary outcomes
1
Description
Brucellosis prevallance
Timepoint
Before intervention and 6 month after intervention
Method of measurement
The brucellosis prevalence index
Secondary outcomes
1
Description
Self efficacy related to prevention of Brucellusis
Timepoint
Before intervention and 6 month after intervention
Method of measurement
questionnaire based on Precede Proceed Model
2
Description
Social environment related to prevention of Brucellusis
Timepoint
Before intervention and 6 month after intervention
Method of measurement
The questionnaire based on Precede Proceed Model
3
Description
Reinforcing factors related to prevention of Brucellusis
Timepoint
Before intervention and 6 month after intervention
Method of measurement
questionnaire based on Precede Proceed Model
4
Description
Knowledge related to prevention of Brucellusis
Timepoint
Before intervention and 6 month after intervention
Method of measurement
Questionnaire based on Precede Proceed Model
5
Description
Attitudes related to prevention of Brucellusis
Timepoint
Before intervention and 6 month after intervention
Method of measurement
questionnaire based on Precede Proceed Model
6
Description
Behaviour related to prevention of Brucellusis
Timepoint
Before intervention and 6 month after intervention
Method of measurement
Questionnaire based on Precede Proceed Model
7
Description
Gereal health
Timepoint
Before intervention and 6 month after intervention
Method of measurement
General Health queationnaire (GHQ 12)
8
Description
Quality of life
Timepoint
Before intervention and 6 month after intervention
Method of measurement
Quality of life questionnaire Short form 12 (SF 12)
Intervention groups
1
Description
Control group: This group willl receive the required educations after completion of study.
Category
Prevention
2
Description
Intervention group: receiving the comprehensive education based on Precede Proceed Model for prevention of Brucellosis that the number of education sessions will determine after pre-test and primary assessment.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rural Health Houses
Full name of responsible person
Babak Mahdavi
Street address
Rural Health Houses of Ahar, Ahar county, East Azarbayjan
City
Ahar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Asghari JafarAbadi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Golgasht street, Azadi Street, Tabriz, East Azarbayjan
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Babak Mahdavi
Position
Health worker
Other areas of specialty/work
Street address
Ahar rural Health Services, Emam Street, Ahar, East Azarbayjan
City
Ahar
Postal code
Iran
Phone
+98 41 3325 7580
Fax
Email
jahangiryleila@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Jahangiry
Position
PhD
Other areas of specialty/work
Street address
Health Education and Promotion departement, Public Health Faculty, Tabriz University of Medical Sciences, Golgasht street, Azadi Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3325 7580
Fax
Email
jahangiryleila@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Jahangiry
Position
Assisatant Professor
Other areas of specialty/work
Street address
Health Education and Promotion departement, Public Health Faculty, Tabriz University of Medical Sciences, Golgasht street, Azadi Street, Tabriz Tabriz
City
Postal code
5376166331
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)