Protocol summary

Summary
The aim of this study was to determine the effect of educational intervention on promoting self- care, knowledge and belief in proper antibiotic use among individuals referee to south health centers of Tehran University of Medical Sciences in 2016-2017: Application of Social Cognitive Theory.This research is a quasi-experimental intervention with two control and intervention groups. Inclusion criteria: people over 18 years old ,attending the health centers in south of Tehran. Exclusion criteria: No tendency to participate the study.Study population includes people over 18 years old attending the health centers in south of Tehran. sample size is 260(130 participants intervention group and 130 participants in control group). In this study there has been employed a cognitive-social theory based- questionnaire including demographic information, the structures of social-cognitive theory, self-care questions, public awareness and beliefs . Pre-test is taken from both groups. Intervention program will take place over a month of training sessions (four weeks with one session weekly) in form of blended education training (lecture ,question and answer). Every session will take 30 to 45 minutes. In these sessions, the attempt is sharing necessary information and instructions on the concept of self-care and rational use of antibiotics . Six months later, in order to assess the interventional program effects, the questionnaire will be completed again for both groups. The primary outcome of this study are awareness, general belief and social cognitive theory structures .The study not blinded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092412460N11
Registration date: 2016-11-16, 1395/08/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-11-16, 1395/08/26
Registrant information
Name
Roya Sadedgi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 327 5692
Email address
sadeghir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for education of Tehran University of Medical Sciences and Vice chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of educational intervention on promoting self- care, knowledge and belief in proper antibiotic use among individuals referee to south health centers of Tehran University of Medical Sciences in 2016-2017: Application of Social Cognitive Theory
Public title
Effect of education on promoting self- care related to proper antibiotic use
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: people over 18 years old ;attending the health centers in south of Tehran؛ satisfaction to study participate Exclusion criteria: No tendency to participate the study؛ being absent in two sessions from four Sessions
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 260
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
Ethics commitee of Tehran University of Medical Sciences
Street address
Tehran.Poursina Ave
City
Tehran
Postal code
Approval date
2016-09-04, 1395/06/14
Ethics committee reference number
IR.TUMS.SPH.REC.1395.553

Health conditions studied

1

Description of health condition studied
Proper antibiotic usage
ICD-10 code
Z70-Z76
ICD-10 code description
Factors influencing health status and contact with health services

Primary outcomes

1

Description
General belief
Timepoint
Baseline and six months later
Method of measurement
Questionnaire

2

Description
Social-cognitive theory constructs
Timepoint
Baseline and six months later
Method of measurement
Questionnaire

3

Description
Knowledge
Timepoint
Baseline and six months later
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Social-cognitive theory constructs
Timepoint
Baseline and six months
Method of measurement
Questionnaire

2

Description
Self-care
Timepoint
Baseline and six months
Method of measurement
Questionnaire

Intervention groups

1

Description
In control group ,education will be conducted based on rou tine plan of health centers.
Category
Prevention

2

Description
Intervention program will take place over a month of training sessions (four weeks with one session weekly) in form of blended education training (lecture ,question and answer). 130 participants intervention group and 130 participants in control group. Every session will take 30 to 45 minutes. In these sessions, the attempt is sharing necessary information and instructions on the concept of self-care and rational use of antibiotics.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
South health centers of Tehran University of Medical Sciences
Full name of responsible person
Mr.Javad Barzegari
Street address
NO.4 , Shafeei Alley , Quods Ave. , Enghelab Square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for education of Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohamad Jalili
Street address
Central Organization of Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for education of Tehran University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Masoud Younesian
Street address
Central Organization of Tehran University of Medical Sciences
City
Tehran
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 Tehran University of Medical Sciences
Proportion provided by this source
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 Sciences
Full name of responsible person
Dr.Roya Sadeghi
Position
Academic staff
Other areas of specialty/work
Street address
School of Public Health, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 912 327 5692
Fax
Email
sadeghir@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Position
PhD
Other areas of specialty/work
Street address
School of Public Health, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 4293 3210
Fax
Email
sadeghir@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
Dr.Roya Sadeghi
Position
PhD
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
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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