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The effect of an educational intervention designed based on family - centered empowerment model in modifying risk behaviors in patients with brucellosis in Chaldran in 2013

Protocol summary

Summary
This study aimed to empower patients with brucellosis. This study was an experimental intervention. Participants were selected from patients with brucellosis. The main inclusion criteria were being infected with brucellosis, consent for participation in the study and exclusion criteria were refusal for participation in the study. The sample size was obtained 32 patients for each group, of course considering probability of loss of patients around 20%, The sample size was 39 persons for each group. After selecting the intervention and control groups, the data was collected in two stages: The first phase of data collection was before the intervention, the second stage was two months after the intervention. Data was collected using a questionnaire based on the family-centered empowerment model. In the stage before the intervention, the per-test was performed in both intervention and control groups ,and after analyzing the data, resources, limitation, needs, and strengths and weaknesses in different fields were identified , then type of content, teaching methods, time and the number of training sessions were designed based on the steps. Outcomes were evaluating the empowerment of patients before and after intervention. The Intervention group: In this study the intervention was holding the training sessions. The intervention was based on information obtained from the questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013112515422N1
Registration date: 2013-12-21, 1392/09/30
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-12-21, 1392/09/30
Registrant information
Name
Towhid Babazadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 9118
Email address
t-babazadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-03-01, 1392/12/10
Expected recruitment end date
2014-04-30, 1393/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an educational intervention designed based on family - centered empowerment model in modifying risk behaviors in patients with brucellosis in Chaldran in 2013
Public title
The effect of education on the prevention of high risk behaviors in patients with brucellosis
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria of the study include: being infected with brucellosis; alive; city residents Chaldiran present consent to participate in the study Exclusion criteria include: Migration of the city Chalderan study period, the subjects of death, not satisfied to continue to participate in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
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
Tehran University of Medical Sciences
Street address
Sixth Floor, Central University, Qods Street, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2013-11-11, 1392/08/20
Ethics committee reference number
92-02-27-2290-98382

Health conditions studied

1

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

Primary outcomes

1

Description
High risk behaviors
Timepoint
Before the intervention and 2 months after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Attitudes about the disease brucellosis
Timepoint
Before the intervention and 2 months after intervention
Method of measurement
Questionnaire

2

Description
Self esteem about the disease brucellosis
Timepoint
Before the intervention and 2 months after intervention
Method of measurement
Questionnaire

3

Description
Self efficacy about the disease brucellosis
Timepoint
Before the intervention and 2 months after intervention
Method of measurement
Questionnaire

4

Description
Knowledge about the disease brucellosis
Timepoint
Before the intervention and 2 months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
The Intervention group: In this study the intervention will be holding the training sessions. The intervention would be based on information obtained from the questionnaire.
Category
Prevention

2

Description
The control group: Training in groups is not but after the end of data collection in the end of study, educational pamphlets and pamphlets will be given to the control group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Chaldran Health Network
Full name of responsible person
Towhid Babazadeh
Street address
Chaldran Health Network, City Chaldoran, West Azerbaijan province
City
Chaldoran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Simin Naseri
Street address
Central Organization of Tehran University of Medical Sciences, Qods St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Science
Full name of responsible person
Towhid Babazadeh
Position
student
Other areas of specialty/work
Street address
Central Organization of Tehran University of Medical Sciences, Qods St, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 8898 7381
Fax
Email
towhid.babazadeh@live.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Towhid Babazadeh
Position
Masters
Other areas of specialty/work
Street address
School of Public Health, Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 8898 7381
Fax
Email
towhid.babazadeh@live.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Towhid Babazadeh
Position
Student
Other areas of specialty/work
Street address
School of Public Health, Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 8898 7381
Fax
Email
towhid.babazadeh@live.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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