The impact of self-care education on awareness, attitude and quality of life in patients with asthm referred Shahid Beheshti hospital to clinic of Hamedan university of medical sciences
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Ethics committees
#1
IR.UMSHA.REC.1396.670
IR.UMSHA.REC.1396.725
IR.UMSHA.REC.1396.670IR.UMSHA.REC.1396.725
Protocol summary
Study aim
Determining the effect of self-care education on knowledge, attitude and quality of life in asthmatic patients
Design
A randomized, controlled clinical trial of 104 patients
Settings and conduct
The purpose of this study was to determine the effect of self-care education on knowledge, attitude and quality of life of asthmatic patients referred to Shahid Beheshti hospital of Hamedan University of Medical Sciences. The number of samples in this study is 104 patients. In this study, patients were randomly divided into two groups of intervention and control. In the intervention group, educational intervention will be performed in 4 sessions, but in the control group, except for routine care, no action will be taken. 8 weeks after the end of the intervention, the questionnaires will be completed by the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20 and 65 years, Suffering from asthma, Not having other chronic diseasesa
Exclusion criteria: Exit for any reason during the study, such as death, dissatisfaction to continue participating in the study
Intervention groups
In the intervention group, self-care education will be given in four sessions.The first session includes anatomy and physiology training, the second session includes how to adhere to the proper diet, how to adhere to the prescribed regimen, the third session includes daily activities, exercise, stress-avoidance education. The fourth session involves training skills such as the use of respiratory sprays. Then, 8 weeks after the completion of the interventions, the questionnaires are given to two groups.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N7
Registration date:2018-02-06, 1396/11/17
Registration timing:prospective
Last update:2018-02-23, 1396/12/04
Update count:1
Registration date
2018-02-06, 1396/11/17
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-09, 1396/11/20
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of self-care education on awareness, attitude and quality of life in patients with asthm referred Shahid Beheshti hospital to clinic of Hamedan university of medical sciences
Public title
Impact of self-care education on awareness, attitude and quality of life in patients with asthma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 65 years
Suffering from asthma
Not having other chronic diseases
Exclusion criteria:
Dissatisfaction to continue participating in the study
Exit for any reason during the study, such as death
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly,104 patients are selected. Then, using random blocks, they will be divided equally in to two groups of intervention and control
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 Hamedan University of Medical Sciences
Street address
Shahid Fahmideh St, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2018-01-13, 1396/10/23
Ethics committee reference number
IR.UMSHA.REC.1396.725
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Quality of life
Timepoint
Before anf after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Self-care education will be given in four sessions.The first session includes anatomy and physiology training, the second session includes how to adhere to the proper diet, how to adhere to the prescribed regimen, the third session includes daily activities, exercise, stress-avoidance education. The fourth session involves training skills such as the use of respiratory sprays
Category
Lifestyle
2
Description
Control group: Except for routine care, no action will be taken.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Amir Sadeghi
Street address
Shahid Fahmideh St, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
sadeghi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Amir Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
sadeghi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Amir Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
sadeghi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Somayeh Kokabi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
kokabiam.s@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