The effect of education-modificational intervention on psychosocial factors and asthma control among adolescents with asthma in respiratory speciality clinics of Tabriz -2011
The purpose of this study is to assess the effect of education-modificational intervention on psychosocial factors ( attitude, self-efficacy,quality of life) and asthma control. The research is experimental study and based on pretest-posttest control group design. A sample of 60 adolescents with asthma from 12 thru 18 years of age in respiratory speciality clinics participate in the study. Groups will be assigned randomly to intervention and control groups.Measurements of attitudes, quality of life, self- efficacy, and asthma control. Questionnaires will be collected prior intervention and five week post intervention in both groups. Intervention group receive the asthma face to face education program from asthma booklet and telephone follow up. Asthma education program is designed as four session,with emphasize on triggers of asthma and how to modification and control these triggers. Each session will take 20-30 min and trigger modification individually plan will be perform at last session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112078315N1
Registration date:2012-05-06, 1391/02/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-06, 1391/02/17
Registrant information
Name
Leila Valizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
valizadehl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education-modificational intervention on psychosocial factors and asthma control among adolescents with asthma in respiratory speciality clinics of Tabriz -2011
Public title
The effect of education-modificational intervention on psychosocial factors and asthma control among adolescents with asthma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 12–18 years old; Asthma diagnosis ≥ 1 year ; having moderate or severe persistent asthma had physician-diagnosed; live in Tabriz and suburb; being able to read and write; being satisfied to participate in the study and no mental disability.
Exclusion criteria: having other acute diseases and esophageal reflux, sinusitis, rhinitis ; change the location of Tabriz and suburb and incomplete participated in educational sessions.
Age
From 12 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Tabriz Medical Sciences Ethic Commette
Street address
Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Approval date
2011-11-21, 1390/08/30
Ethics committee reference number
9051
Health conditions studied
1
Description of health condition studied
asthma
ICD-10 code
J45
ICD-10 code description
Mixed asthma
Primary outcomes
1
Description
Attitude
Timepoint
prior intervention and five week post intervention
Method of measurement
Child Attitude Toward Illness Scale
2
Description
Self-Efficacy
Timepoint
prior intervention and five week post intervention
Method of measurement
Child Asthma Self-Efficacy scale
3
Description
Quality of Life
Timepoint
prior intervention and five week post intervention
Method of measurement
Mini Pediatric Asthma Quality of Life Questionnaire (Mini PAQLQ)
Secondary outcomes
1
Description
Asthma control
Timepoint
prior intervention and five week post intervention
Method of measurement
Asthma Control Diary Questionnaire (modified)
Intervention groups
1
Description
Asthma education program is designed as four face to face sessions,with emphasize on triggers of asthma and how to modification and control these triggers. An individual modificational planning for identify and modify asthma triggers will perform last session. Each session will take 20-30 min.
Category
Behavior
2
Description
control group: routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikhalraeis speciality clinic
Full name of responsible person
Soheila Zarei
Street address
Maralan Square, Azady street
City
Tabriz
2
Recruitment center
Name of recruitment center
Pediatric Respiratory speciality clinic
Full name of responsible person
Soheila Zarei
Street address
Maralan Squre, Azady Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz International University of Medical Sciences (Aras)
Full name of responsible person
Mahmood Nazarpoor
Street address
Imam khomeini Street
City
Jolfa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz International University of Medical Sciences (Aras)
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
Tabriz University of Medical Sciences
Full name of responsible person
Soheila Zarei
Position
MS nursing Student
Other areas of specialty/work
Street address
Tabriz Faculty of Nursing and Midwifery,South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1443 2402
Fax
+98 41 1478 1496
Email
zareisoheila68@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Valizadeh
Position
Assistant professor
Other areas of specialty/work
Street address
Tabriz Faculty of Nursing and Midwifery,South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
valizadehl@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Soheila Zarei
Position
MS Nursing Student
Other areas of specialty/work
Street address
Tabriz Faculty of Nursing and Midwifery,South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1478 1497
Fax
+98 41 1478 1497
Email
zareisoheila68@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)