Protocol summary

Study aim
The effect of elderly pharmacovigilance education on nurses knowledge ,attitude and practice .
Design
Clinical trial with community-based control group with paralell and non-randomized groups
Settings and conduct
The place of the study was a two-dimensional educational program that was selected randomly. An educational intervention was conducted on the test group and its website. The training content included defining drug safety, defining the side effects of drugs, and reporting it as PowerPoint.
Participants/Inclusion and exclusion criteria
Having a bachelor's degree and having a minimum of six years of carbineering experience, getting to know the internet and having no history of training on the safety principles of medicine in the last 3 months Non-compliance criteria: Failure to answer or incomplete response to questions that will be omitted from the examples.
Intervention groups
This research was done before and after the test and control. The nurses will select a center for the control group and no interventions will be performed on them. Then their educational intervention on the principles of drug safety in the elderly will be done in the second center of therapy (in the test group) through the website of that center. Before the intervention, each group was subjected to a pre-test and then a subtest was taken from each group.
Main outcome variables
Increasing the knowledge of nurses about the safety of medicines and paying attention to them in the care of the elderly, The attention of nursing managers to modern teaching methods in nursing and its application on the web site, Applying the Behavioral Education Method for Nurses in the Morning Shift, Night Era.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180620040169N1
Registration date: 2018-07-16, 1397/04/25
Registration timing: retrospective

Last update: 2018-07-16, 1397/04/25
Update count: 0
Registration date
2018-07-16, 1397/04/25
Registrant information
Name
Mitra Bouzari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2631 2264
Email address
bozari.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
2017-07-23, 1396/05/01
Actual recruitment end date
2017-09-21, 1396/06/30
Trial completion date
empty
Scientific title
The effect of elderly pharmacovigilance education on nurses knowledge ,attitude and practice .
Public title
The effect of elderly pharmacovigilance education on nurses knowledge ,attitude and practice .
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All employed nurses Have 6 months working experience ]ntroduction to the Internet Not having a history of drug safety training in the last 3 months At least 25 years old
Exclusion criteria:
Lack of work experience Not familiar with the computer
Age
From 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 100
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 iran university of medical science
Street address
Shahidisemi Street, Faculty of Nursing
City
Tehran
Province
Tehran
Postal code
1996713883
Approval date
2017-06-26, 1396/04/05
Ethics committee reference number
IR.Iums.Fmd.Rec9413580001

Health conditions studied

1

Description of health condition studied
pharmacovigilance
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Average knowledge score
Timepoint
Before entering it and 2 Hfth dimension
Method of measurement
Drug Safety Inventory

2

Description
Before entering it and 2 Hfth dimension
Timepoint
Average performance score
Method of measurement
Drug Safety Inventory

3

Description
Average performance score
Timepoint
Average performance score
Method of measurement
Drug Safety Inventory

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, after the test, the training of the safety of the drugs was carried out through a hospital nursing website for 2 weeks. The training was based on PowerPoint. After that, the contents of the hospital were removed from the hospital website after the follow up.
Category
Behavior

2

Description
In the control group, no intervention was performed after the pre-test.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Hasheminejad Hospitals, Shafaei Haiyan
Full name of responsible person
Ezzat Jafarjalal
Street address
Vanak Square, Provincial Street, Hashemi Nejad Hospital
City
Tehran
Province
Tehran
Postal code
1631998151
Phone
+98 21 81161
Fax
Email
E-jafarjalal@tums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
ِDR. Kazem Malakouti
Street address
Hammet Highway - Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
80
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
Iran University of Medical Sciences
Full name of responsible person
Mitra Bouzari
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
MajidiehAve. Kazemi st. N. 4
City
Tehran
Province
Tehran
Postal code
1631998151
Phone
+98 21 2631 2264
Email
Mitra.bouzari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ezzat Jafarjalal
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University of Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4413
Email
E-jafarjalal@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mitra Bouzari
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
MajidiehQucha-Kazem-iPlaca 4
City
Tehran
Province
Tehran
Postal code
1631998151
Phone
+98 21 2631 2264
Email
Mitra.Bouzari@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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
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