Protocol summary

Study aim
This study will be done to determine the effect of educational intervention based on family empowerment model for the modify of High-Risk Behaviors among Patients With Brucellosis
Design
120 people were selected from the villages under study. The assignment of the groups was non-random, the villages of Torbat-e Jam are listed and 2 villages will be randomly selected as the intervention group. Then two villages will be selected as control group that are culturally and socially similar to the two intervention villages, but they are not geographically close.then 30 people are randomly selected from each village.
Settings and conduct
Educational intervention will be implemented with an emphasis on family empowerment model, for a maximum of 3 months on intervention group. Educational intervention will take place in 6 one-hour training sessions. The training sessions will be held in a group discussion. In this study, considering the characteristics of the target group and the objectives of the curriculum will be used various oral, written and combination methods and methods used by the media for training such as lectures with questions and answers, providing and presenting suggestions, group discussion, practical presentation, role play and the provision of educational media such as booklets, posters and educational CDs are provided in the form of a training package for independent study for learners
Participants/Inclusion and exclusion criteria
Inclusion criteria: Residence for at least 6 months in the research setting؛ Exclusion criteria: One of the family member has the Brucellosis
Intervention groups
Intervention group: Educational intervention is done with an emphasis on family empowerment model Control Group: No intervention
Main outcome variables
preventive behavior of Brucellosis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160619028529N12
Registration date: 2020-03-24, 1399/01/05
Registration timing: registered_while_recruiting

Last update: 2020-03-24, 1399/01/05
Update count: 0
Registration date
2020-03-24, 1399/01/05
Registrant information
Name
Hadi Tehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3853 8530
Email address
tehranih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-05, 1398/12/15
Expected recruitment end date
2020-05-04, 1399/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational Intervention Based on Family Empowerment Model for The Modify of High-Risk Behaviors among Patients With Brucellosis In Rural Areas
Public title
The effect of intervention to promoting the preventive behavior of Brucellosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Residence for at least 6 months in the research setting
Exclusion criteria:
One of the family member has the Brucellosis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Qoreishi Building, Daneshgah 18, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-10-12, 1398/07/20
Ethics committee reference number
IR.MUMS.REC.1398.199

Health conditions studied

1

Description of health condition studied
Brucellosis
ICD-10 code
A23
ICD-10 code description
Brucellosis

Primary outcomes

1

Description
preventive behavior of Brucellosis
Timepoint
before the intervention, immediately and, 2 months after the intervention
Method of measurement
Questionnaire, Behavioral View Checklist

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group": Educational intervention will be implemented with an emphasis on family empowerment model, for a maximum of 3 months on intervention group. Educational intervention will take place in 6 one-hour training sessions. The training sessions will be held in a group discussion. In this study, considering the characteristics of the target group and the objectives of the curriculum will be used various oral, written and combination methods and methods used by the media for training.
Category
Lifestyle

2

Description
Control group: No intervention
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
villages of Torbat-e Jam
Full name of responsible person
Maryam al-Sadat Shojaee
Street address
School of Public Health, between 16th and 18th Daneshgah, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2210
Email
ShojaeiM961@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice President of Research, Qoreishi Building, Daneshgah 18, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 1538
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion. School of Public Health, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2203
Email
tehranih@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion. School of Public Health, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2203
Email
tehranih@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion. School of Public Health, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2203
Email
tehranih@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Not applicable
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
Title and more details about the data/document
Potential data is sharable after distinguishing people
When the data will become available and for how long
Start the access period one month after the publication of result
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data is sent through an official request and by email
From where data/document is obtainable
ِDr Hadi Tehrani: tehranih@mums.ac.ir
What processes are involved for a request to access data/document
Data is sent through an official request and by email
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