Research on Disease Control and Mental Health Status of Adolescent Asthma Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-18
SponsorBeijing Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Children with other respiratory diseases such as bronchiectasis, bronchiolitis, cystic fibrosis and pneumonia
Combined with chronic diseases of other systems
Trial population
This study recruited children with asthma and their parents from the hospital outpatient clinic as research participants. The inclusion criteria were: meeting the GINA 2025 diagnostic criteria for asthma; children aged 12-18 years; and both parents and children provided informed consent and were able to complete the questionnaires. The exclusion criteria were: children with other respiratory diseases such as bronchiectasis, bronchiolitis, cystic fibrosis, or pneumonia; and those with other chronic systemic diseases including diabetes, kidney disease, lupus erythematosus, skin diseases, epilepsy, heart disease, or arthritis.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Eligible participants will complete a battery of assessment questionnaires
Other interventionData on demographic characteristics, asthma control status, anxiety and depression symptoms, self-management self-efficacy, and transition readiness were collected via standardized questionnaires
Treatment groups
460 Participants
are divided into 1 treatment groupGroup A: Adolescent asthma patients1 intervention
Trial outcomes
Primary outcomes
1
anxiety state
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.
Time frame
From the diagnosis of asthma to the end of this survey at 12month2
depression state
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.
Time frame
From the diagnosis of asthma to the end of this survey at 12monthSecondary outcomes
1
disease control level
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.
Time frame
From the 4 weeks prior to enrollment to the end of this survey at 12month2
Adolescent readiness for the transition period of asthma
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.
Time frame
From the diagnosis of asthma to the end of this survey at 12monthLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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