Self EfficacyNCT06045312
The Effect of Online Peer and Adult Education Given to Adolescents With Allergic Asthma
A study testing education in people with Self Efficacy and Asthma, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: To examine the effect of interactive online education given by peers or adults on anxiety, self-efficacy, quality of life, and disease knowledge and management in adolescents with allergic asthma in the 10-14 age group. Methods: The research was conducted as a randomized controlled study. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Self Efficacy, Asthma, Asthma in Children
- What is being tested?
- education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 May 2019to 21 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age was 10 to 14 years, doctor-diagnosed allergic asthma, without allergic rhinitis with a diagnosis of allergic asthma (by medical record), internet access via computer or phone, the ability to speak Turkish, willingness to participate.
- Exclusion criteria were those with moderate to severe cognitive or mental health impairment and a diagnosis of allergic rhinitis in addition to the diagnosis of allergic asthma (according to medical records).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University, Nursing Faculty
Aydin
About this study
Official title: The Effect of Online Peer and Adult Education Given to Adolescents With Allergic Asthma on Their Quality of Life, Self-Efficacy, Anxiety, and Disease Knowledge and Management: A Randomized Controlled Study
Objectives: To examine the effect of interactive online education given by peers or adults on anxiety, self-efficacy, quality of life, and disease knowledge and management in adolescents with allergic asthma in the 10-14 age group.
Methods: The research was conducted as a randomized controlled study. The study sample consisted of 84 adolescents divided into experimental groups [receiving peer(n=28) or adult(n=28) education] and control(n=28) group. The adolescents in the peer or adults were given online interactive education concerning allergic asthma and the management thereof. The control group received only usual training.Data were collected using an Adolescent Personal Data Form, the State Anxiety Inventory for Children, the Self-Efficacy Scale for Children and Adolescents with Asthma, the Pediatric Asthma Quality of Life Questionnaire, and the Disease Knowledge and Management Questionnaire. Data were collected from the adolescents before (T0) and immediately after education (T1), and after one (T2) and three months (T3).
This study is a non-blinded randomized controlled trial. . All screened adolescents with asthma were randomly assigned to one of the three groups: the peer or adults education groups that received a 6 weeks asthma education and a control group that received usual care. The three groups were then followed prospectively immediately, 1, and 3 months after training to evaluate the effectiveness of training compared with usual care.
- Conditions
- Self Efficacy, Asthma, Asthma in Children
- Being tested
- education
- Keywords
- Adolescent, Anxiety, Asthma, Knowledge, Self-efficacy, Quality of life
- Medical subject headings
- Asthma, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
Comparison of the effectiveness of peer or adult education to adolescents with asthma
| Study group | Role | What they receive |
|---|---|---|
| peer education | Experimental | peer-trained group Receives: Other: education |
| adult education | Experimental | adult-trained group Receives: Other: education |
| control | No intervention | no education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy (SES)
The SES determines the degree of self-confidence of children and adolescents with asthma in taking precautions against their disease and in seeking medical assistance. This scale has 22 items. The highest possible score is 110 and the powest possible score is 22. The cut-off point score is 88. Accordingly, a score below 88 is interpreted as indicating low self-efficacy, while a score of 88 or above is interpreted as indicating high self-efficacy
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start19 May 2019
- Primary completion20 Jul 2020
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, there is an intervention and a control group.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelin Karataş, Aydin Adnan Menderes University
- Investigators
- pelin karataş, MsC, Principal investigator, aydın adnan menderes universtyHüsniye Çalışır, Study director, aydın adnan menderes universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045312
- Sponsor's protocol ID
- HF-20005
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Online Peer and Adult Education Given to Adolescents With Allergic Asthma on Their Quality of Life, Self-Efficacy, Anxiety, and Disease Knowledge and Management: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06045312
- Acronym / sponsor ID
- HF-20005
- Conditions
- Self Efficacy, Asthma, Asthma in Children
- Keywords
- Adolescent, Anxiety, Asthma, Knowledge, Self-efficacy, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 19 May 2019 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: To examine the effect of interactive online education given by peers or adults on anxiety, self-efficacy, quality of life, and disease knowledge and management in adolescents with allergic asthma in the 10-14 age group.
Methods: The research was conducted as a randomized controlled study. The study sample consisted of 84 adolescents divided into experimental groups [receiving peer(n=28) or adult(n=28) education] and control(n=28) group. The adolescents in the peer or adults were given online interactive education concerning allergic asthma and the management thereof. The control group received only usual training.Data were collected using an Adolescent Personal Data Form, the State Anxiety Inventory for Children, the Self-Efficacy Scale for Children and Adolescents with Asthma, the Pediatric Asthma Quality of Life Questionnaire, and the Disease Knowledge and Management Questionnaire. Data were collected from the adolescents before (T0) and immediately after education (T1), and after one (T2) and three months (T3).
This study is a non-blinded randomized controlled trial. . All screened adolescents with asthma were randomly assigned to one of the three groups: the peer or adults education groups that received a 6 weeks asthma education and a control group that received usual care. The three groups were then followed prospectively immediately, 1, and 3 months after training to evaluate the effectiveness of training compared with usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In this study, there is an intervention and a control group.
| Arm | Type | Receives |
|---|---|---|
| peer education | Experimental | Other: educationpeer-trained group |
| adult education | Experimental | Other: educationadult-trained group |
| control | No intervention | –no education |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age was 10 to 14 years, doctor-diagnosed allergic asthma, without allergic rhinitis with a diagnosis of allergic asthma (by medical record), internet access via computer or phone, the ability to speak Turkish, willingness to participate.
- Exclusion criteria were those with moderate to severe cognitive or mental health impairment and a diagnosis of allergic rhinitis in addition to the diagnosis of allergic asthma (according to medical records).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educationComparison of the effectiveness of peer or adult education to adolescents with asthma | Other | adult education, peer education |
Primary outcome
Self-Efficacy (SES)
Time frame: 10 months
The SES determines the degree of self-confidence of children and adolescents with asthma in taking precautions against their disease and in seeking medical assistance. This scale has 22 items. The highest possible score is 110 and the powest possible score is 22. The cut-off point score is 88. Accordingly, a score below 88 is interpreted as indicating low self-efficacy, while a score of 88 or above is interpreted as indicating high self-efficacy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
pelin karataş, MsC principal investigator
aydın adnan menderes universty
Hüsniye Çalışır study director
aydın adnan menderes universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Self Efficacy and Asthma, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Efficacy (SES) (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.