- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07412119
Research on Disease Control and Mental Health Status of Adolescent Asthma Patients
Background: Currently in China, adolescent asthma care is characterized by both undertreatment and overtreatment. Patients in this age group may exhibit negative emotions toward disease treatment and long-term control. Insufficient disease knowledge, irregular lifestyle habits, and negative attitudes toward the disease can all reduce medication adherence, affect disease control outcomes, and thereby increase the risk of severe chronic respiratory conditions and disease burden in adulthood.
Objectives: To assess disease control status in adolescent asthma patients, evaluate the psychological well-being of patients and their family members, and understand patients' self-management skills and readiness for transition to adulthood.
Procedures: Eligible participants will complete a series of assessment questionnaires through the Youran Huxi mobile application, including questionnaires on asthma control, physical activity, psychological health, self-management behaviors, and transition readiness. The study period is 12 months; the baseline assessment involves one-time completion of written questionnaires with no interim follow-up visits. The study does not intervene in clinical diagnosis or treatment decisions.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kunling Prof.Shen
- Phone Number: 0755-83008286
- Email: hanpengonly1@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Meet the asthma diagnostic criteria of GINA 2025
- Age 12 to 18 years old
- The parents and the child patient agreed and filled out the questionnaire completely.
Exclusion Criteria:
- Children with other respiratory diseases such as bronchiectasis, bronchiolitis, cystic fibrosis and pneumonia
- Combined with chronic diseases of other systems
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adolescent asthma patients
Adolescents diagnosed with asthma
|
Data on demographic characteristics, asthma control status, anxiety and depression symptoms, self-management self-efficacy, and transition readiness were collected via standardized questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anxiety state
Time Frame: From the diagnosis of asthma to the end of this survey at 12month
|
Total scores on the Screen for Childhood Anxiety and Related Emotional Disorders (SCARED) ranging from 0 to 24 are considered within the non-clinical range, indicating minimal anxiety symptoms. SCARED total scores of 25-41 indicate mild to moderate anxiety symptoms. Scores of 42 or above suggest moderate to severe anxiety symptoms, indicating probable anxiety disorder. |
From the diagnosis of asthma to the end of this survey at 12month
|
|
depression state
Time Frame: From the diagnosis of asthma to the end of this survey at 12month
|
A score of 16 to 19 on the Child Depression Scale (CDI) indicates mild depressive symptoms, and attention should be paid to psychological state. A score of 20 to 24 indicates moderate depressive symptoms. A score of 25 or above indicates severe depressive symptoms, suggesting the possible presence of depressive disorders. |
From the diagnosis of asthma to the end of this survey at 12month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
disease control level
Time Frame: From the 4 weeks prior to enrollment to the end of this survey at 12month
|
The Asthma Control Test (ACT) will be employed for assessment, with the following interpretation criteria: A total score of 20-25 indicates well-controlled asthma; A score of 16-19 suggests poorly controlled asthma; A score of 5-15 reflects very poorly controlled asthma. |
From the 4 weeks prior to enrollment to the end of this survey at 12month
|
|
Adolescent readiness for the transition period of asthma
Time Frame: From the diagnosis of asthma to the end of this survey at 12month
|
The STARx Transition Readiness Questionnaire (scale) is suitable for patients aged 12 to 22 and is filled out by adolescent patients. There are a total of 6 dimensions, divided into drug management (4 items), doctor-patient communication (3 items), participation in medical visits (3 items), assumption of health responsibility (2 items), disease knowledge (3 items), and resource utilization (3 items), totaling 18 items. It is divided into five levels from 1 to 5, each assigned a score of 1, 2, 3, 4, and 5 respectively. The transition period preparation score is the sum of the scores of each item. The higher the score, the more thorough the transition period preparation and the better the self-care ability. |
From the diagnosis of asthma to the end of this survey at 12month
|
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
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Hypersensitivity
- Pathological Conditions, Signs and Symptoms
- Behavior
- Personal Satisfaction
- Asthma
- Disease
- Psychological Well-Being
Other Study ID Numbers
- Adolescent Asthma 001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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