NCT Number: NCT07523724
The aim of this study is to develop and validate a digital screening tool and digital management system for asthma and allergic diseases among Chinese adults and to evaluate the effectiveness of integrated non-pharmacological interventions in improving disease control and quality of life.
The digital management cohort consists of:
* At least 12 months of longitudinal monitoring of symptoms, environmental exposures, and health behaviors via a digital platform, supplemented by regular clinical assessments. * 3x embedded randomized controlled trials (RCTs) evaluating the clinical efficacy of non-pharmacological strategies: allergen avoidance (anti-mite bedding), physical activity (wearable-guided exercise), and dietary management (Mediterranean diet).
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Not applicable
Early identification and sustained management are crucial for mitigating the growing public health burden of asthma and allergic diseases. This study implements a coherent system spanning from population-level assessment to individualized, long-term care. The primary objectives are to:
Validate a culturally adapted screening questionnaire and an integrated digital health platform for the Chinese population.
Establish a prospective longitudinal cohort to investigate disease progression and evaluate the clinical efficacy of non-pharmacological interventions via embedded randomized controlled trials (RCTs).
The investigators will enroll approximately 9,666 first-year university students into a hybrid study that combines a digital cohort with targeted intervention trials. Following initial tool validation, large-scale screening will be conducted during entrance health check-ups. Individuals identified through screening or with self-reported allergic conditions will be invited to join a longitudinal management cohort for at least one year of follow-up.
Within this monitoring framework, eligible participants will be recruited into three distinct embedded RCTs evaluating non-pharmacological strategies:
Longitudinal follow-up utilizes a mixed-methods strategy, integrating passive self-reporting every 3 months via the digital platform with active researcher-led assessments every 6 months, including clinical laboratory testing (IgE, FeNO) and spirometry. This approach allows for the investigation of complex interactions between genetic susceptibility and environmental exposures in disease expression.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants received standardized allergen avoidance measures, with the primary goal of reducing allergen exposure levels. Specific measures included regularly implementing allergen avoidance behaviors and recording environmental parameters. The operational details were carried out in accordance with the research protocol. During the intervention period, the original medication treatment was maintained.
Participants receive a standardized exercise promotion program, which included, but is not limited to, regular face-to-face guidance, motivational interviews, personalized goal setting, action planning, and self-feedback and adjustment based on objective activity monitoring data. During the intervention period, the subjects maintain their original medication treatment plans unchanged.
Participants receive standardized guidance on a healthy diet pattern. The intervention measures included, but are not limited to, guidance from nutritionists, provision of food materials, and monitoring of dietary compliance. During the intervention period, the subjects maintain their original medication treatment plans unchanged.
Participants eceive usual care, consisting of standard pharmacological treatment. They are instructed to maintain their baseline lifestyle and activity levels without participating in additional allergen avoidance interventions.
Participants continue their routine clinical treatment and do not receive dietary interventions. At baseline, all participants watch a 10-minute asthma self-management education video that does not contain dietary advice.
Participants receive usual care, consisting of standard pharmacological treatment. They are instructed to maintain their baseline lifestyle and activity levels without participating in additional exercise interventions.
Time frame: 3 months
Patient health-related outcomes, specifically the level of asthma control, were measured using the pre-validated Asthma Control Test (ACT). This tool consists of 5 questions, each scored on a scale from 1 to 5. A total score of 19 or less indicates that the patient's asthma may not be well-controlled, signaling a need for clinical re-evaluation and potential adjustments to their treatment regimen. A score of 15 or less suggests that the asthma is poorly controlled or completely uncontrolled.
Time frame: 3 months
Change in Asthma Quality of Life Questionnaire score in the intervention group. Values range 7-224, with higher scores indicating better quality of life.
Time frame: 3 months
The usage of drugs during the follow-up period
Time frame: 3 months
An acute asthma exacerbation is characterized by a rapid onset or progressive worsening of symptoms-including wheezing, dyspnea, chest tightness, and coughing-accompanied by a decline in lung function.
Contact information is provided by the study sponsor or research team.
Xunliang Tong, MD
CONTACT
Yating Wang
CONTACT
Beijing Hospital
Other Gov
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07728578
Asthma, Bronchial Diseases
Damietta, Egypt
View Trial DetailsNCT05776927
Asthma, Bronchial Diseases
View Trial DetailsNCT07712393
Asthma, Bronchial Diseases
View Trial DetailsNCT07654842
Asthma, Bronchial Diseases
Skokie, Illinois, United States
View Trial Details