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| Name | Class |
|---|---|
| Chinese Academy of Medical Science & Peking Union Medical College School of Population Medicine and Public Health | UNKNOWN |
| Jilin University | OTHER |
| The First Hospital of Jilin University | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allergen Avoidance Intervention - group 2 | Placebo Comparator |
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| Exercise Intervention - group 2 | Placebo Comparator |
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| Dietary Intervention - group 2 | Placebo Comparator |
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| Allergen Avoidance Intervention - group 1 | Experimental |
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| Exercise Intervention - group 1 | Experimental |
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| Dietary Intervention - group 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergen Avoidance Intervention - group 1 | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Test | 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. | 3 months |
| Quality of life score | Change in Asthma Quality of Life Questionnaire score in the intervention group. Values range 7-224, with higher scores indicating better quality of life. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Drug usage | The usage of drugs during the follow-up period | 3 months |
| Acute asthma exacerbation | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunliang Tong, MD | Contact | +86 18610021799 | tongxunliang@163.com | |
| Yating Wang | Contact | +86 13521760029 | b2024021020@student.pumc.edu.cn |
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3 randomised controlled trials (RCTs), embedded within the cohort study.
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| Exercise Intervention - group 1 | Behavioral | 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. |
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| Dietary Intervention - group 1 | Behavioral | 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. |
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| Allergen Avoidance Intervention - group 2 | Behavioral | 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. |
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| Dietary Intervention - group 2 | Behavioral | 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. |
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| Exercise Intervention - group 2 | Behavioral | 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. |
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| 3 months |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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