1. Home
  2. Approved trials
  3. » فارسی

The effect of a Self-care Education Package based on a Mobile phone Application on Sleepiness and Medication Adherence in Adolescents with Allergic Rhinitis

Protocol summary

Study aim
Determining the Effect of Self-care Education Package based on Mobile phone Application on Sleepiness and Medication Adherence in Adolescents with Allergic Rhinitis.
Design
Randomized clinical trial with intervention and control groups, on 74 Patients
Settings and conduct
In this study, adolescents (12-19 years old) with allergic rhinitis who refer to specialized and sub-specialized asthma and allergy clinics in Yasouj city; will participate The researched samples will be selected according to the available method and will be divided into intervention and control groups by random block allocation. The intervention group will receive self-care training based on a mobile application designed for this purpose, and the control group will receive only training and usual treatment by a specialist physician.
Participants/Inclusion and exclusion criteria
Inclusion criteria : 1) Diagnosis of allergic rhinitis by a specialist doctor 2) Consent to participate in the study and sign the informed consent form by the parent and teenager 3) Age range between 12-19 years 4) access to a smartphone or tablet to implement the application 5) Having a minimum level of elementary literacy 6) Obtaining a score of 9 or higher on the sleepiness scale of Epworth 7) Obtaining a score of 6 or less in the Moriski medication adherence scale Exclusion criteria: 1) Suffering from other chronic diseases 2) Having cognitive disorders 3) History of participating in similar training courses in the last six months
Intervention groups
In this study, after designing and developing the mobile application, this application will be available to the intervention group for 8 weeks and its outcomes will be measured. In addition; In the control group, the usual treatment and training will be given.
Main outcome variables
Sleepiness; Medication adherence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240424061558N1
Registration date: 2024-05-02, 1403/02/13
Registration timing: prospective

Last update: 2024-05-02, 1403/02/13
Update count: 0
Registration date
2024-05-02, 1403/02/13
Registrant information
Name
Hesamoddin Khalesro
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3311 3022
Email address
hesamkhro@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a Self-care Education Package based on a Mobile phone Application on Sleepiness and Medication Adherence in Adolescents with Allergic Rhinitis
Public title
TheEffect of Education based on Mobile phone Application on Sleepiness and Medication Adherence in Allergic Rhinitis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of allergic rhinitis by a specialist doctor Consent to participate in the study and sign the informed consent form by the parent and teenager Age range between 12-19 years Access to a smartphone or tablet to implement the application Having a minimum level of elementary literacy Obtaining a score of 9 or higher on the sleepiness scale of Epworth Obtaining a score of 6 or less in the Morisky medication adherence scale
Exclusion criteria:
Suffering from other chronic diseases Having cognitive disorders History of participating in similar training courses in the last six months
Age
From 12 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, adolescents (12-19 years old) with allergic rhinitis who refer to specialized and sub-specialized asthma and allergy clinics in Yasouj city; will participate The researched samples will be selected according to the available method and will be divided into intervention and control groups by random block allocation. In this way, first by multiplying the number of studied groups (two groups) by 2, the number of samples in each block is calculated equal to 4, then by factorial calculation, the number of samples in each block (24=1×2×3×4= 4), the number of blocks resulting from all modes of arrangement of people, 24 blocks were calculated, then, since the number of people in each block was 4, there were 4 participants in each block (2 participants from each group) whose arrangement was different. is, there will be Therefore, the blocks will be randomly selected by placement, with the selection of each block, there are 4 participants in it, and the allocation method is also known. ABCD, ABDC, ACBD, ACDB, ADBC, ADCB, BACD, BADC, BCAD, BCDA, BDAC, BDCA, CABD, CADB, CBAD, CBDA, CDAB, CDBA, DABC, DACB, DBAC, DBCA, DCAB, DCBA Group labeling have been determined randomly and by lottery that A=intervention, B=control, C=control and D=intervention. They will be assigned a code, and by matching that number with the random block allocation list, the patients participating in the research will be assigned to one of the intervention and control groups.
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
Research Ethics Committees of Yasuj University of Medical Sciences
Street address
Shahid Motahhari Blvd., Headquarters of Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2024-04-24, 1403/02/05
Ethics committee reference number
IR.YUMS.REC.1403.008

Health conditions studied

1

Description of health condition studied
Allergic Rhinitis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sleepiness score on the Epworth Sleepiness Scale
Timepoint
At the beginning of the study (before the intervention), week 4 and week 8 after the study
Method of measurement
Epowrth Sleepiness Scale

2

Description
Medication adherence score in Morisky Medication Adherence Scale
Timepoint
At the beginning of the study (before the intervention), week 4 and week 8 after the study
Method of measurement
Morisky Medication Adherence Scale-8

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After designing and developing the mobile application, it will be provided to the intervention group
Category
Treatment - Devices

2

Description
Control group: During this period, no intervention will be done on the control group and they will only receive the usual care and treatment and will receive the necessary and common training during the visit by the doctor.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mofateh Clinic
Full name of responsible person
Hesamoddin Khalesro
Street address
Golestan 15 ST., Pasdaran Blvd,.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
9417694780
Phone
+98 87 3311 3022
Email
hesamkhro@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossaini Motlaghh
Street address
Research Assistant. Yasuj University of Medical Sciences. Shahid Motahari Blvd.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
aminhomo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Hesamoddin Khalesro
Position
Student of Master Of Science in Pediatrics Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
qasedak2 Ave., Parto St., 5Azar town
City
Sanandaj
Province
Kurdistan
Postal code
6619981731
Phone
+98 87 3311 3022
Email
hesamkhro@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hesamoddin Khalesro
Position
Student of Master Of Science in Pediatrics Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
qasedak2 Ave., Parto St., 5Azar town
City
Sanandaj
Province
Kurdistan
Postal code
6619981731
Phone
+98 87 3311 3022
Email
hesamkhro@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hesamoddin Khalesro
Position
Student of Master Of Science in Pediatrics Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
qasedak2 Ave., Parto St., 5Azar town
City
Sanandaj
Province
Kurdistan
Postal code
6619981731
Phone
+98 87 3311 3022
Email
hesamkhro@gmail.com

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
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data relevant to the study's main outcome will be published.
When the data will become available and for how long
Available after results are published
To whom data/document is available
Access for researchers
Under which criteria data/document could be used
In order to conduct research on qualified person
From where data/document is obtainable
To receive documents, send a message to hessamkhro@gmail.com
What processes are involved for a request to access data/document
The applicant can access the data after submitting the application and meeting the conditions and checking it
Comments
Loading...