Protocol summary

Summary
The main purpose: to determine the effect of educational intervention based on Health Belief Model on reducing arbitrary antibiotic use in women referred to health units under covering south Tehran Health Center Secondary objectives: To Compare the grade of knowledge, susceptibility, severity, benefits and perceived barriers and advantages and self-reported performance before and 3 months after educational intervention in two studied groups, determination of the frequency distribution of practice guides of arbitrary use of antibiotics and most Antibiotics used by the studied population Study design: Intervention study and a clinical trial is to determine the effect of education on reducing arbitrary use of antibiotics and will be carried out in the level of health care units covered by health center of the south of Tehran. Health center of the south of Tehran has 31 centers and 53 health centers in five municipal districts 10, 11, 16, 17 and 19. How to do: First a list of all health facilities is provided by region and municipality and then two health centers is randomly selected from each region. Then again two randomly selected centers take place in intervention and control groups. For sampling each two groups, they simultaneously select someone who have study criteria. To measure the designed questionnaire used, First, the questionnaire of participants in both intervention and control groups were completed, then the program is done in the experimental group. After the end of 3 months the data again are collected from both groups and then analyzed. Entrance condition: Individuals in the intervention group: women with 15 to 60 years old who have health records have been referred to the health centers in the considered date are allowed to participate in the study. Exclusion criteria included the lack of their desire to continue to participate in the study and absence of more than one meeting of the three sessions. Intervention: 1- holding three training class sessions, each session lasting 30 minutes. 2- Flyer installing 3- pamphlet distribution 4- educational pamphlet distribution 15- sending 12 SMS during the 3 months training course Variables: In this study, knowledge, perceived susceptibility and severity in people taking the antibiotic arbitrary, obstacles and benefits of the correct use of antibiotics as the dependent variable and age, education level, occupation, nationality, type of insurance, marital status, spouse education, jobs and average of family income as independent variables is considered in the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020726416N1
Registration date: 2016-09-25, 1395/07/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-25, 1395/07/04
Registrant information
Name
Elham Rashidian
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 4427 9087
Email address
e-rashidian@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analysis of the effect of the education intervention based on the model of health belief on irrational use of antibiotic among women referring to health care centers under the coverage of the Health Care Center of SouthTehran in 2016
Public title
The impact of education on antibiotic use
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: females referred to the health center; aged between 15 and 60 years old; having health records in health centers; can participate in training classes and satisfied to participate in the study. Exclusion criteria: the reluctance of women to continue participating in the study; absence of more than one session in a training classes.
Age
From 15 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 720
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Organization of Tehran University of Medical Sciences- Quds Street- Keshavarz Blvd.
City
tehran
Postal code
Approval date
2015-12-19, 1394/09/28
Ethics committee reference number
IR.TUMS.REC.1394.1437

Health conditions studied

1

Description of health condition studied
Antibiotic use
ICD-10 code
xx1
ICD-10 code description
Factors influencing health status and contact with health services

Primary outcomes

1

Description
Reduce antibiotic use
Timepoint
3 months
Method of measurement
Using questionnaires

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, first the questionnaire is completed, then educational intervention is done as following: 1- 3 training class held for 30 minutes at health centers. 2. The educational pamphlet are available to participants .3- educational flyer is installed in front of the eyes of participants. 4- 12 SMS will be sent to the participants’ mobile numbers (a massage every 2 weeks). 4- At last meeting the participants will be given educational pamphlets. Then after three months the same questionnaire is completed.
Category
Prevention

2

Description
In the control group the questionnaire is completed and three months later the same questionnaire of participants in the control group is completed.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center south of Tehran
Full name of responsible person
Elham Rashidian
Street address
Street Revolution-Street Vesal SHirazi- Alley SHafiee- Health center south of Tehran
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
School of Health, Tehran University of Medical Sciences
Full name of responsible person
Gholam Reza Garmaroudi
Street address
Department of Health Promotion, Faculty of Public Health, Tehran University of Medical Sciences, Poursina 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
School of Health, 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
South Tehran Health Center
Full name of responsible person
Elham Rashidian
Position
MSc Student
Other areas of specialty/work
Street address
South Tehran Health Center, Shafie Alley, Vesal Shirazi St.
City
Tehran
Postal code
1417863181
Phone
+98 21 6647 7188
Fax
Email
e-rashidian@farabi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Gholam Reza Garmaroudi
Position
Maternal and Child Health Specialist, MSc, MPH mental health
Other areas of specialty/work
Street address
Department of Health Promotion, Faculty of Public Health, Tehran University of Medical Sciences, Poursina St., Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 8898 9134
Fax
+98 21 8898 9129
Email
garmaroudi@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Rashidian
Position
Masters student
Other areas of specialty/work
Street address
Department of Health Promotion, Faculty of Public Health, Tehran University of Medical Sciences, Poursina St., Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 6647 7188
Fax
+98 21 6647 7188
Email
e-rashidian@farabi.tums.ac.ir; elirashidian@yahoo.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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