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Screening and Management of Adults With Asthma and Allergic Diseases

ConditionsAsthmaAllergic Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBeijing Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years

Capable of providing informed consent and completing the questionnaire independently.

Disqualifiers

Individuals with serious chronic diseases, immune disorders, or severe psychiatric/cognitive conditions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

9,666 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Allergen Avoidance Intervention - group 2Placebo comparator 1 intervention
Group B: Exercise Intervention - group 2Placebo comparator 1 intervention
Group C: Dietary Intervention - group 2Placebo comparator 1 intervention
Group D: Allergen Avoidance Intervention - group 1Experimental treatment 1 intervention
Group E: Exercise Intervention - group 1Experimental treatment 1 intervention
Group F: Dietary Intervention - group 1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months
2

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.

Time frame
3 months

Secondary outcomes

1

Drug usage

The usage of drugs during the follow-up period

Time frame
3 months
2

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.

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Hospital

Lead sponsor

Chinese Academy of Medical Science & Peking Union Medical College School of Population Medicine and Public Health

Collaborator

Jilin University

Collaborator

The First Hospital of Jilin University

Collaborator

Source ClinicalTrials.gov

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