The effect of education on influenza vaccination In selected patients with chronic diseases (diabetes ,pulmonary diseases ,Hemodialysis ,heart disease )in the shahrood in 2018
Effect of training on influenza vaccination in pulmonary, cardiovascular diseases, hemodialysis and diabetic patients in the Shahrood in 2018.
Design
This study is a randomized, not blinded clinical trial. The study is parallel group design with 1:1 allocation ratio.
The study population is selected from patients with pulmonary, cardiovascular diseases, hemodialysis and diabetic patients.
The sample size is 80 people. Patients are divided into two intervention and control groups through randomized blocks. 80 patients would enroll between November 2018 and October 2018, and will follow for six months.
Settings and conduct
The study will conduct on referral patients to a specialized clinic in Imam Hossein Hospital at Shahrood.
Assignment of patients to intervention and control groups will be done.
In this study, not blind.
Participants/Inclusion and exclusion criteria
The inclusion criteria:history of pulmonary, cardiovascular diseases, hemodialysis and diabetes.Referring to specialized clinic, At least 18 years old, Minimum elementary education, Interest in participating in the study
The exclusion criteria: History of participation in influenza vaccine training classes, Inability to have regular attendance at training sessions and The presence of any influenza vaccine sensitivity
Intervention groups
Educational intervention is performed based on the theory of planned behavior.3 sessions are arranged once a week
Summary of training sessions:
Definition of the disease
Determine the mental norms
Determine the control of perceived behavior
For the control group, the same sessions will be completed after the end of the study.
Main outcome variables
Influenza vaccine injection rate in selected patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180526039841N1
Registration date:2018-06-14, 1397/03/24
Registration timing:prospective
Last update:2018-06-14, 1397/03/24
Update count:0
Registration date
2018-06-14, 1397/03/24
Registrant information
Name
mina khanhoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3577 5300
Email address
khanhoseini@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education on influenza vaccination In selected patients with chronic diseases (diabetes ,pulmonary diseases ,Hemodialysis ,heart disease )in the shahrood in 2018
Public title
The effect of education on influenza vaccination
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
any patients with pulmonary, cardiovascular and Hemodialysis disease, and diabetes volunteered for study
Lack history of participation vaccination training classes
People over 18 years old
a minimum level of elementary education
acceptance for participate in the research
Exclusion criteria:
Unwilling to participate in the study
No regular attendance at training sessions
The presence of any influenza vaccine susceptibility
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study we used random blocking method for randomization.
Randomization unit was individual.
Stratified random sampling was done before we use random block method, because we need to recruit 10 patients from selected diseases (DM, Hemodialysis, Cardiovascular & pulmonary).
Randomization tool was random numbers table.
Blinding (investigator's opinion)
Not blinded
Blinding description
This study is a not blinded clinical trial.
Since training to patients is done by someone other than the principal investigator, then study is not blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Emam Hossein Square, Emam Hossein Hospital
City
Shahrood
Province
Semnan
Postal code
36147-73947
Approval date
2017-10-27, 1396/08/05
Ethics committee reference number
SHMU.REC.1395.61
Health conditions studied
1
Description of health condition studied
pulmonary and heart and hemodylsis and diabetes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Influenza vaccination rate in selected patients
Timepoint
Beginning of study and 1 weak and 2 weak after education
Method of measurement
Researcher made questionnaire
Secondary outcomes
1
Description
The effect of education on influenza vaccination
Timepoint
At the beginning of the study, and then one week after the end of the training classes
Method of measurement
Researcher made questionnaire
Intervention groups
1
Description
Intervention group: Pulmonary and diabetic and hemodialysis and cardiovascular patients.In the intervention group, intervention was conducted based onTheory of Planning Behavior For each group of patients in the intervention arm, 3 sessions are arranged once a week according to scheduled and pre-announced schedules in the clinic.Before the beginning of the sessions in the intervention group, a briefing is conducted for 30 minutes (referrals, group norms, statement of goals). It should be noted that a briefing session is organized for 4 groups of patients in intervention and control groups. The structure of the meetings is based on the table drawn up (appended). After completing the training program, in the 4 groups of patients, the intervention arm after completing the initial question during the final session; 2 by phone call with intervals of 1 week by the researcher. intervention as well as in the control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized Clinic of Imam Hossein Shahroud Hospital
Full name of responsible person
Mina khanhoseini
Street address
Imam hosein Hospital ,Imam hosein Squre
City
Shahrood
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3234 2000
Email
khanhoseini@shmu.ac.ir
2
Recruitment center
Name of recruitment center
Specialized Clinic of Imam Hossein Shahroud Hospital
Full name of responsible person
Mina khanhoseini
Street address
Emam Hosein Hospital,Emam Hosein Squre
City
Shahrood
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3234 2000
Email
Khanhoseini@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mina khanhoseini
Street address
Emam Hosein Hospital, Emam Hosein Squre
City
Shahrood
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3234 2000
Email
khanhoseini@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
100
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
Shahroud University of Medical Sciences
Full name of responsible person
mina khanhoseini
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Emam hosein Hospital,Emam hosein Squre
City
Shahrood
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3234 2000
Email
khanhoseini@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mina khanhoseini
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Emam hosein Hospital , Emam hosein Squre
City
Shahrood
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3234 2000
Email
khanhoseini@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
mina khanhoseini
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Emam hosein Hospital , Emam hosein Squre
City
Shahrood
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3234 2000
Email
khanhoseni@shmu.ac.ir
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
Yes - There is 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
Title and more details about the data/document
The main message is shared
When the data will become available and for how long
A few months after printing results
To whom data/document is available
Available to scientific institutions
Under which criteria data/document could be used
Educational
From where data/document is obtainable
email
What processes are involved for a request to access data/document