Screening and Management of Adults With Asthma and Allergic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9,666
- 主要终点
- Asthma Control Test
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years
- •Capable of providing informed consent and completing the questionnaire independently.
排除标准
- •Individuals with serious chronic diseases, immune disorders, or severe psychiatric/cognitive conditions.
研究组 & 干预措施
Exercise Intervention - group 2
干预措施: Exercise Intervention - group 2 (Behavioral)
Exercise Intervention - group 1
干预措施: Exercise Intervention - group 1 (Behavioral)
Dietary Intervention - group 1
干预措施: Dietary Intervention - group 1 (Behavioral)
Allergen Avoidance Intervention - group 2
干预措施: Allergen Avoidance Intervention - group 2 (Behavioral)
Dietary Intervention - group 2
干预措施: Dietary Intervention - group 2 (Behavioral)
Allergen Avoidance Intervention - group 1
干预措施: Allergen Avoidance Intervention - group 1 (Behavioral)
结局指标
主要结局
Asthma Control Test
时间窗: 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.
Quality of life score
时间窗: 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.
次要结局
- Drug usage(3 months)
- Acute asthma exacerbation(3 months)