NCT06045312

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

August 31, 2023

Last Update Submit

September 13, 2023

Conditions

Keywords

AdolescentAnxietyAsthmaKnowledgeSelf-efficacyQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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

    10 months

Study Arms (3)

peer education

EXPERIMENTAL

peer-trained group

Other: education

adult education

EXPERIMENTAL

adult-trained group

Other: education

control

NO INTERVENTION

no education

Interventions

Comparison of the effectiveness of peer or adult education to adolescents with asthma

adult educationpeer education

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University, Nursing Faculty

Aydin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AsthmaAnxiety Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • pelin karataş, MsC

    aydın adnan menderes universty

    PRINCIPAL INVESTIGATOR
  • Hüsniye Çalışır

    aydın adnan menderes universty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: In this study, there is an intervention and a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 21, 2023

Study Start

May 19, 2019

Primary Completion

July 20, 2020

Study Completion

October 21, 2021

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations