- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06392490
The Effectiveness of Peer-education Programs for Adolescents Diagnosed With Asthma
Evaluation of the Effectiveness of a Technology-based Program Delivered by Peer-led and Adult Educators to Adolescents Diagnosed With Asthma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Asthma is the most common chronic disease in children. Although asthma often occurs in childhood, it can occur at any age. The incidence and prevalence of asthma is higher in children. On average, 5-10% of the world's population has an individual diagnosed with asthma, and one-third of these individuals are under the age of 18. In the United States of America (USA), approximately 6 million children between the ages of 0-17 are diagnosed with asthma. It has been reported that adolescents are at high risk for poor asthma outcomes, and death rates from asthma are twice as high in the 11-17 age group than in the 0-10 age group.
Peer relationships and peer support are of particular importance for children with chronic illnesses. Adolescents diagnosed with asthma value support from their peers. Adolescents tend to seek guidance from people with similar characteristics, and the opinions of individuals with similar characteristics are more valuable than those of individuals who do not have similar characteristics. Being with an adolescent diagnosed with asthma can improve the adolescent's sense of support and sense of normalcy. It is crucial to create an environment where adolescents diagnosed with asthma can interact with other adolescents diagnosed with asthma, thereby facilitating the formation of a support network.The research was planned in a randomized controlled trial to evaluate the effect of technology-based education provided by peers and adults to children diagnosed with asthma in the 12-18 age group. The study group of the study will consist of 45 adolescents (intervention group 1 [n=15], intervention group 2 [n=15], and control group [n=15]). The technology-based program will be applied to adolescents for 4-6 weeks through modules on the website. At the end of the study, it will apply website modules to the adolescents in the control group. The research is based on the Bandura's Self-Efficacy Theory.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emine Gunes San, MSc
- Phone Number: +905543545596
- Email: eminegunessan@hotmail.com
Study Locations
-
-
-
Ankara, Turkey
- Emine Gunes San
-
Contact:
- Emine Gunes San, MSc
- Phone Number: +905543545596
- Email: eminegunessan@hotmail.com
-
Sub-Investigator:
- Naime Altay, Prof.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The study population is comprised of individuals between the ages of 12 and 18 who have been diagnosed with asthma at least three months prior and who do not have any other medical diagnoses of chronic disease. Additionally, they must own and be able to use a smartphone, reliable home internet access, and a computer. Furthermore, they must be proficient in Turkish and not be in the active attack period. Finally, they must not have experienced a stressful event that could affect their quality of life in the last three months, such as an acute illness, the birth of a new sibling, or the death of a family member.
Exclusion Criteria:
- Those who are unwilling or unable to continue the research Those who fail to participate in the internet-based application on two or more occasions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Peer Group
-The experimental group that will apply the technology-based psychosocial program from peers
|
Evaluate the impact of peer-led and adult-based technology-based education on the quality of life, asthma control, asthma knowledge and self-efficacy in adolescents diagnosed with asthma.
|
Other: Adult Group
-The group that will apply the technology-based psychosocial program from adult
|
Evaluate the impact of peer-led and adult-based technology-based education on the quality of life, asthma control, asthma knowledge and self-efficacy in adolescents diagnosed with asthma.
|
No Intervention: Control Group
Control group that will no apply the technology-based psychosocial program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adolescent Asthma Self-Efficacy Questionnaire
Time Frame: Change from Baseline level to 3 months (change is being assessed)
|
The scale is applied to adolescents aged 12-18 with a diagnosis of asthma.
Scale items are scored from 0 to 100.
The responses to the scale items are added and then divided by 27 to obtain the total average score (0-100).
Subscale items are added in the same way and divided by the number of items in each subscale.
A higher score indicates higher self-efficacy.
|
Change from Baseline level to 3 months (change is being assessed)
|
Asthma Quality of Life Scale for Children
Time Frame: Change from Baseline level to 3 months (change is being assessed)
|
The instrument was developed to assess the physical, mental and social disorders of children diagnosed with asthma in the 7-17 age group.
The scores range from 23 to 161.
The items on the scale are evaluated using a 7-point Likert scale.
A high score indicates a high quality of life, while a low score indicates a low quality of life.
|
Change from Baseline level to 3 months (change is being assessed)
|
Asthma Control Test
Time Frame: Change from Baseline level to 3 months (change is being assessed)
|
The Asthma Control Test (ACT) is a five-item instrument designed to assess asthma control.
The ACT scores range from 5 to 25, with a score of 5 indicating poor asthma control and a score of 25 indicating complete control of asthma.
A score below 19 is generally used to indicate uncontrolled asthma.
|
Change from Baseline level to 3 months (change is being assessed)
|
Asthma knowledge test
Time Frame: Change from Baseline level to 3 months (change is being assessed)
|
This form will be created by researchers in accordance with the existing literature.
It will be used to evaluate information about asthma symptoms, triggers and treatment.
The form will be created in a 3-point Likert type as "True", "False" and "I don't know".
In the form, each correct answer will receive "1 point", while incorrect answers and those marked "I don't know" will receive "0 points".
A high total score obtained from this form will indicate a high level of knowledge about asthma.
|
Change from Baseline level to 3 months (change is being assessed)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-Gazi-SBE-E.896440
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Universita di VeronaCompleted
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
-
Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany
Clinical Trials on Technology Based Asthma Program
-
Susan LutgendorfUniversity of Miami; University of Iowa; University of WashingtonRecruiting
-
Virginia Commonwealth UniversityCompletedPregnancy RelatedUnited States
-
Wayne State UniversityCompletedAsthma | Poor Medication Adherence
-
Gazi UniversityNot yet recruitingCancer | Parents | Child, Only | EmpowermentTurkey
-
Wayne State UniversityNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting
-
Gazi UniversityNot yet recruitingCancer | Child, Only | Empowerment
-
Cumhuriyet UniversityRecruitingOverweight and ObesityTurkey
-
Henry Ford Health SystemUniversity of Michigan; Augusta University; Children's Hospital of MichiganCompletedAcute AsthmaUnited States
-
Gazi UniversityNot yet recruitingChild Rearing | Growth and Development | Early Childhood Caries