Protocol summary

Summary
This clinical trial study will do to assess the effect of education based on health belief model on preventive behaviors of Hepatitis B in addicts during 2015. In this study, 84 subjects who are in maintenance phase of methadone and don't afflicted by hepatitis B and have clinical record in public treatment of abuse Hamedan Samiee 8 Center will inter into the study. Exclusion criteria include lack of consent for continuing research and absenteeism in more than half of educational sessions. Subjects will allocate to control and intervention group according to table of random numbers. At first, both groups fulfill preventive behaviors of Hepatitis B questionnaire and then subjects in intervention group will divide to 6 groups with 7 individuals in each group and will receive education through lecture in 3 sessions based on health belief model, while subjects in control group receive routine education. Two months after the last session, preventive behaviors of Hepatitis B questionnaire will complete again in both groups and pre and post results of intervention in each group as well as results of both groups will compare.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015090114251N5
Registration date: 2015-10-21, 1394/07/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-21, 1394/07/29
Registrant information
Name
MORTEZA NASIRI
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 2622 5292
Email address
nasiri.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of research and technology of Hamadan University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of education based on health belief model and routine education on preventive behaviors of Hepatitis B in addicts
Public title
Effect of education based on health belief model on preventive behaviors of Hepatitis B
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: subjects who are in maintenance phase of methadone and have clinical record in public treatment of abuse Hamedan Samiee 8 Center; lack of hepatitis B; trend to participate in educational classes as well as research. Exclusion criteria: lack of consent for continuing research; exist of subjects from study due to any reason such as migration and lack of referee to recruitment center for continuing treatment; absenteeism in more than half of educational sessions.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 84
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
Hamadan University of Medical Sciences Ethics Committee
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave, Hamedan.
City
Hamadan
Postal code
Approval date
2015-04-11, 1394/01/22
Ethics committee reference number
UMSHA.REC.1394،39

Health conditions studied

1

Description of health condition studied
Hepatitis
ICD-10 code
B16.9
ICD-10 code description
Acute hepatitis B without delta-agent and without hepatic coma

Primary outcomes

1

Description
Preventive behaviors
Timepoint
Before and one month after the intervention
Method of measurement
Researcher-made questionnaire

Secondary outcomes

1

Description
Perceived susceptibility
Timepoint
Before and two months after intervention
Method of measurement
Researcher-made questionnaire

2

Description
Perceived severity
Timepoint
Before and two months after intervention
Method of measurement
Researcher-made questionnaire

3

Description
Perceived benefits
Timepoint
Before and two months after intervention
Method of measurement
Researcher-made questionnaire

4

Description
Perceived bariars
Timepoint
Before and two months after intervention
Method of measurement
Researcher-made questionnaire

5

Description
Perceived self-efficacy
Timepoint
Before and two months after intervention
Method of measurement
Researcher-made questionnaire

Intervention groups

1

Description
Subjects in intervention group will divide to 6 groups with 7 individuals in each group and will receive education through lecture in 3 sessions based on health belief model.
Category
Prevention

2

Description
Subjects in control group will receive routine education.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Public Treatment of Abuse Hamedan Samiee 8 Center
Full name of responsible person
Mitra Salehikhah
Street address
Public Treatment of Abuse Hamedan Samiee 8 Center, Mazghineh avenue, Hamadan
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor of research and technology of Hamadan University of Medical Sciences
Full name of responsible person
Dr. Saied Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh avenue, Hamedan, Iran.
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of research and technology of Hamadan 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
Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran
Full name of responsible person
Mitra Salehikhah
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh avenue, Hamedan, Iran.
City
Hamadan
Postal code
Phone
+98 77 3532 5292
Fax
Email
salehikhah_mitra@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Mitra Salehikhah
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh avenue, Hamedan, Iran.
City
Hamadan
Postal code
Phone
+98 77 3532 5292
Fax
Email
salehikhah_mitra@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mitra Salehikhah
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh avenue, Hamedan, Iran.
City
Hamadan
Postal code
Phone
+98 77 3532 5292
Fax
Email
salehikhah_mitra@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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