Determining the effect of theory-based training on asthma control behaviors in asthmatic women referred to Amirul Mominin Hospital in Arak
Design
The study population is 80 women with asthma, 40 of whom are randomly assigned to the intervention group and 40 to the control group.
Settings and conduct
This study is conducted in the city of Arak to educate women with asthma. In this study, it is a randomized controlled trial that is selected by simple random and placed in intervention and control groups.
Participants/Inclusion and exclusion criteria
1. A person suffering from asthma with a doctor's confirmation
2. Not suffering from other chronic diseases, such as chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis, emphysema, and small airways disease.
3. Age 18 to 65 years
4. Not having communication problems such as deafness and being literate
5. Living in Arak for at least one year
Intervention groups
The desired training program is implemented in a combined way (direct training including group discussion, lectures, questions and answers, film showing and indirect training including distribution of pamphlets and educational booklets). Based on the needs assessment, the number of sessions and the method are determined. The training is based on the health belief model in the field of prevention of exposure to air pollution, medication compliance and dietary compliance in women with asthma for the intervention group.
Main outcome variables
The main outcome variable is performing asthma disease control behaviors (including medication adherence, avoiding exposure to air pollution, and following diet) in women with asthma.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231126060178N1
Registration date:2023-12-06, 1402/09/15
Registration timing:prospective
Last update:2023-12-06, 1402/09/15
Update count:0
Registration date
2023-12-06, 1402/09/15
Registrant information
Name
Fateme Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3465 4680
Email address
f.bagheri@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of theory-based education on asthma control behaviors among women with asthma referred to Amir Al-Momenin Hospital in Arak
Public title
Investigation of the effect of theory-based education on asthma control behaviors among women with asthma referred to Amir Al-Momenin Hospital in Arak
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A person suffering from asthma with a doctor's confirmation
Not suffering from other chronic diseases, such as chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis, emphysema, and small airways disease.
Not having communication problems such as deafness and being literate
Living in Arak for at least one year
Age: 18 to 65 years old
Exclusion criteria:
Leaving for any reason during the study, such as death, relocation and unwillingness to continue participating in the study
Patients with severe asthma are admitted to the ward
Non-attendance of sick women in half of the training sessions
Non-availability of female patients when completing the post-intervention questionnaire
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are coded based on the list prepared by the hospital's information technology department and entered into the SPSS software, and they are divided into two groups. It will be divided by simple random with the above software. Finally, 40 people will be included in each of the groups under study.
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 Arak University of Medical Sciences
Street address
Vice-Chancellor of Education and Research, Pardis Educational Complex, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
38481-7-6941
Approval date
2022-12-05, 1401/09/14
Ethics committee reference number
IR.ARAKMU.REC.1401.258
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Improving the ability of asthmatic women in asthma control behaviors
Timepoint
Before the intervention and three months after the intervention
Method of measurement
In this study, two questionnaires are used: 1- Asthma control questionnaire 2- Theory-based questionnaire to measure the effect of the educational program on the constructs of the health belief model
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the group received the designed educational intervention test. The desired training program is implemented in a combined way (direct training including group discussion, lectures, questions and answers, film showing and indirect training including distribution of pamphlets and educational booklets). Based on the needs assessment, the number of sessions and the method are determined. The training is based on the health belief model in the field of prevention of exposure to air pollution, medication compliance and dietary compliance in women with asthma for the intervention group.
Category
N/A
2
Description
Control group: without educational intervention and 3 months after the implementation of the intervention, the test groups will be checked and compared again through questionnaires.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir al-Mominin hospital in Arak city
Full name of responsible person
Dr. Mohsen Shamsi
Street address
AmirulMominin Medical Education Center, next to Medical Faculty, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3836 0000
Fax
+98 86 3417 3619
Email
it-amiralmomenin@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Davoud Hekmat Po
Street address
Research Assistant, Arak University of Medical Sciences, Pardis Educational Complex, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 6368 4615
Fax
+98 86 6443 3368
Email
dr_hekmat@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Fateme Bagheri
Position
Master's student in health education
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Arak Faculty of Health, Golestan, Mustafa Khomeini
City
Arak
Province
Markazi
Postal code
3818146851
Phone
+98 66 4342 1995
Email
f97bagheri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
dr.mohsen shamsi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Arak Faculty of Health, Golestan, Mustafa Khomeini
City
Arak
Province
Markazi
Postal code
3818146851
Phone
+98 86 3368 4615
Email
dr.shamsi@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fateme bagheri
Position
Master's student in health education
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Arak Faculty of Health, Golestan, Mustafa Khomeini
City
Arak
Province
Markazi
Postal code
3818146851
Phone
+98 86 3342 1995
Email
f97bagheri@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
Not applicable
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