Protocol summary

Study aim
Determining of the effectiveness of educational interventions on outcome of patients with asthma referred to the Asthma and Allergy clinic
Design
Randomized clinical trial with control group
Settings and conduct
Since June 2017 , the Asthma and Allergy Clinic of Taleghani Educational Center in Gorgan
Participants/Inclusion and exclusion criteria
Inclusion criterion: all patients with asthma who come to the Asthma and Allergy Clinic of Taleghani Hospital in Gorgan city, Iran from June 2016. Exclusion criteria: patients with no definite diagnosis of asthma; children under the age of 6 years and over 17 years; patients with other concomitant and effective factors such as congenital and genetic disorders; patients with airway infections.
Intervention groups
Patients with entry criteria are randomly divided into 2 groups: 1) Special education group 2) Non-special education group. All patients receive standardized education and information on the disease, treatment and use of medications.
Main outcome variables
Asthma Control Status

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180131038570N1
Registration date: 2018-03-19, 1396/12/28
Registration timing: retrospective

Last update: 2018-03-19, 1396/12/28
Update count: 0
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Solmaz Kami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3222 7720
Email address
s.kami@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of educational interventions on outcome of patients with asthma referred to the asthma and allergy clinic taleghani hospital in gorgan 2016-2017
Public title
The effect of training on the outcome of treating asthmatic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Asthma Patients Age: 6 to 17 years old Patients who was outpatient and were visited to the Asthma and Allergy Clinic.
Exclusion criteria:
Patients with no definite diagnosis of asthma Children under 6 years old and over 17 years of age Patients with other concomitant and effective illnesses, such as congenital and genetic disorders Patients with airway infection
Age
From 6 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked random allocation method will be used. Randomization is done with random numbers.
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 golestan University of Medical Sciences
Street address
5th Kilometer of gorgan - Sari road, Gorgan, Golestan
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2016-10-02, 1395/07/11
Ethics committee reference number
IR.GOUMS.REC.1395.150

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
Effect of training on asthma control status
Timepoint
Assessment of the state of asthma control at the beginning and end of intervention
Method of measurement
Interview, Spirometry and asthma control test (Asthma Control Test: ACT)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients with asthma 6 to 17 years of age receive special training on asthma . Each session is about half an hour with important points in educational programs that include: 1. Understanding the underlying cause of asthma, 2. The role of drugs and the importance of proper use of them, 3. Skills (using tools, how to evaluate asthma control, Monitoring of symptoms, accurate knowledge of the symptoms and the correct answer to them), 4. The importance of reducing environmental factors and related measures.
Category
Prevention

2

Description
Control group: patients with asthma 6 to 17 years without special training on asthma
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Asthma and Allergy clinic Taleghani Hospital in Gorgan
Full name of responsible person
solmaz kami
Street address
taleghani hospital, janbazan ave, gorgan , golestan , iran
City
gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 1222 6013
Email
S.kami@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
safarnejad
Street address
falsafi complex, kilometer 5 gorgan-sari road, gorgan, golestan
City
gorgan
Province
Golestan
Postal code
4916694667
Phone
+98 17 3243 0310
Email
Info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
solmaz kami
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
taleghani hospital, janbazan ave, gorgan, golestan, iran
City
gorgan
Province
Golestan
Postal code
1234567890
Phone
+98 17 1222 6013
Email
S.kami@goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
arash kalantari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
janbazan ave, gorgan
City
gorgan
Province
Golestan
Postal code
1234567890
Phone
+98 17 1222 6013
Email
S.kami@goums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
solmaz kami
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
janbazan ave
City
gorgan
Province
Golestan
Postal code
1234567890
Phone
+98 17 1222 6013
Email
S.kami@goums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the main outcome can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
no
Under which criteria data/document could be used
no
From where data/document is obtainable
solmaz kami. S.kami@goums.ac.ir
What processes are involved for a request to access data/document
Communicate with the responsible person
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