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Investigating the effect of self-care training using the Teach-Back method on the health-enhancing behaviors of asthma patients

Protocol summary

Study aim
Determining the effect of self-care education using the Teach-back method on the health-promoting behaviors of patients with asthma
Design
A clinical trial with an intervention and control group with parallel groups, randomized using a table of random numbers on 88 patients.
Settings and conduct
Implementation of feedback training method for the intervention group (each person has three training sessions per week, one session for 35-45 minutes individually and with a feedback-based method in the Shahid Muftah Clinic of Yasouj city), after the intervention to ensure the continuation of self-care and Answers to questions, phone follow-ups during a month by the researcher
Participants/Inclusion and exclusion criteria
1) Age above 15 years 2) Not having an education in the department of medical sciences 3) Diagnosis of asthma by a specialist doctor 4) Not having speech, hearing and cognitive and memory defects 5) Not having a mental disorder 6) Failure to participate in simultaneous research projects 7) At least 6 months have passed since the onset of asthma Exit criteria 1. Unwillingness to continue cooperation in the study 2. Non-attendance of the patient in all training sessions 3. Death or migration of the patient
Intervention groups
In the intervention group, there are three training sessions per week, one session for 35-45 minutes individually and in a feedback-oriented way. At the end of the training sessions, pamphlets and brochures will be provided to the intervention group. After the intervention, to ensure the continuation of self-care, guidance, clarification of doubts and answers to questions, telephone follow-ups will be done by the researcher within a month. At the end of the study, educational materials were provided to the control group
Main outcome variables
Self-care education, feedback method, health promoting behaviors, asthma

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230529058325N1
Registration date: 2023-05-31, 1402/03/10
Registration timing: prospective

Last update: 2023-05-31, 1402/03/10
Update count: 0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
Ansarinik Forough
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 342 9562
Email address
foroughansari1400@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-17, 1402/03/27
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of self-care training using the Teach-Back method on the health-enhancing behaviors of asthma patients
Public title
The effect of self-care training in a feedback method on the health-promoting behaviors of patients with asthma
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1) Age above 15 years2) Not having an education in the department of medical sciences3) Diagnosis of asthma by a specialist doctor4) Not having speech, hearing and cognitive and memory defects5) Not having a mental disorder6) Failure to participate in simultaneous research projects7) At least 6 months have passed since the onset of asthma
Exclusion criteria:
Unwillingness to continue cooperation in the study. Absence of the patient in all training sessions. Death or migration of the patient
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
For the random assignment of sample people to one of the intervention and control groups, a random sequence is needed, which was obtained from the main randomization software by considering 10 blocks of 10 according to the following.
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 Hormozgan University of Medical Sciences
Street address
No. 43, 10 Abuzar Street, Masoom Abad, Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591948515
Approval date
2023-05-10, 1402/02/20
Ethics committee reference number
IR.HUMS.REC.1402.034

Health conditions studied

1

Description of health condition studied
بیماران مبتلا به آسم
ICD-10 code
J30-J39
ICD-10 code description
X Diseases of the respiratory system (J30-J39 Other diseases of upper respiratory tract)

Primary outcomes

1

Description
health behaviors score in Walker's Health Promoting Lifestyle Questionnaire (HPLP)
Timepoint
Before the start of the intervention, one month after the intervention
Method of measurement
Walker Health Promotion Lifestyle Questionnaire (HPLP)

Secondary outcomes

1

Description
Walker's health-promoting lifestyle
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Walker health promoting lifestyle questionnaire

Intervention groups

1

Description
Intervention group: In the intervention group, there are three sessions of self-care training using the feedback training method, and each session lasts 30 to 45 minutes.
Category
Lifestyle

2

Description
Control group: The control group does not receive any self-care training
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Muftah Clinic
Full name of responsible person
Foroughansarinik
Street address
Tel Zali neighborhood, Montazeri St., Shahid Muftah Clinic
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591948515
Phone
+98 917 342 9562
Email
frwghansary28@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology
Street address
No. 43, Masoomabad St., Abuzar Boulevard, Abuzar 10
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591948515
Phone
+98 917 342 9562
Email
foroughansari1400@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice President of Research and Technology of Hormozgan 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Foroughansarinik
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 43, Masoom Abad St., Abu Zar Blvd., Abu Zar 10, No
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591948515
Phone
+98 917 342 9562
Email
frwghansary28@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Foroughansarinik
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 43, Masoom Abad St., Abu Zar Blvd., Abu Zar 10, No
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591948515
Phone
+98 917 342 9562
Email
foroughansari1400@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Foroughansarinik
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 43, Masoom Abad St., Abu Zar Blvd., Abu Zar 10, No
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591948515
Phone
+98 917 342 9562
Email
frwghansary28@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Data and information on the main outcome
When the data will become available and for how long
Beginning of the access period from 1403
To whom data/document is available
Researchers working in academic and scientific institutes
Under which criteria data/document could be used
Having a license from a recognized university or scientific center
From where data/document is obtainable
09173429562 frwghansary28@gmail.com
What processes are involved for a request to access data/document
Having a license from a recognized university or scientific center
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