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This study will test whether a personalized mobile application that provides temperature-related health risk warnings and protective recommendations can reduce acute exacerbations in people with chronic obstructive pulmonary disease (COPD). Researchers will compare participants who receive the mobile application in addition to usual care with those who receive usual care alone. The main question is whether the mobile application reduces the number of COPD acute exacerbation events over 12 months. The study will also evaluate secondary outcomes including quality of life, functional capacity, symptoms, psychological status, physiological and biochemical indicators, environmental temperature risk perception, and participants' use of the mobile application.
This study is a proof-of-concept study using a cluster randomized controlled design, with hospitals serving as the unit of randomization. Four eligible hospitals in Beijing will be selected as study sites, and each hospital together with all eligible participants enrolled at that site will be treated as one cluster. Clusters will be randomly assigned in a 1:1 ratio to the intervention group or the control group. In addition to usual COPD care, participants in the intervention group will receive temperature-related health risk warning messages and corresponding protective recommendations generated from real-time meteorological data and individual characteristics through the personalized mobile application. Participants in the control group will receive usual COPD care only without access to the mobile application. The study includes a baseline assessment and a 12-month follow-up period. Study visits will occur at baseline and at 3, 6, 9, and 12 months after enrollment. Baseline assessments will include demographic information, air-conditioner use, smoking and alcohol consumption, health status, acute exacerbation events, quality of life, functional capacity, symptoms, psychological status, environmental temperature perception, and physiological and biochemical indicators. Follow-up assessments will collect acute exacerbation events, quality of life, functional capacity, symptoms, psychological status, physiological and biochemical indicators, environmental temperature perception and participants' use of the mobile application. Due to the cluster design and the nature of the mobile application intervention, study participants and research staff who collect visit data will be unmasked. However, data analysts and members of the endpoint adjudication committee will remain masked to the randomization assignments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized Temperature Risk Intervention + Usual COPD Care | Experimental |
| |
| Usual COPD Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Application-Based Personalized Temperature Health Risk Early Warning Intervention | Other | This study implements a digital early warning intervention targeting personalized temperature-related health risks. The mobile application integrates real-time meteorological data and individual characteristics to generate risk levels and deliver tailored health alerts and guidance aimed at supporting risk management and reducing exposure-related health risks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of COPD Acute Exacerbations | Total number of acute exacerbations of COPD managed at home, via outpatient visits, emergency department visits, or hospitalizations. | 12 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Home-managed COPD Acute Exacerbations | Number of home-managed COPD acute exacerbations | 6 and 12 months after baseline |
| Number of Outpatient-managed COPD Acute Exacerbations | Number of outpatient-managed COPD acute exacerbations |
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Hospital inclusion criteria:
Patient inclusion criteria:
Hospital exclusion criteria:
Patient exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Can Zhang, Ph.D. | Contact | +8613655181384 | zhangcan@nieh.chinacdc.cn |
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Due to the cluster design and the nature of the mobile application intervention, study participants and research staff who collect visit data will be unmasked. However, data analysts and members of the endpoint adjudication committee will remain masked to the randomization assignments.
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| 6 and 12 months after baseline |
| Number of Emergency Department-managed COPD Acute Exacerbations | Number of emergency department-managed COPD acute exacerbations | 6 and 12 months after baseline |
| Number of Hospitalized COPD Acute Exacerbations | Number of hospitalized COPD acute exacerbations | 6 and 12 months after baseline |
| Changes in St. George's Respiratory Questionnaire for COPD Patients Score | The St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) score ranges from 0 to 100. Higher scores indicate a worse outcome (poorer health-related quality of life). | 3, 6, 9, and 12 months after baseline |
| Changes in EuroQol 5-Dimension 5-Level Score | The EuroQol 5-Dimension 5-Level (EQ-5D-5L) score consists of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes five dimensions, where higher scores indicate worse health status. The VAS asks respondents to rate their overall health status on a 0-100 scale. Higher scores on the VAS mean a better outcome (better self-rated health status). | 3, 6, 9, and 12 months after baseline |
| Change from Baseline in Forced Expiratory Volume in 1 Second | Forced Expiratory Volume in 1 Second (FEV1) will be measured in liters using spirometry. | 6 and 12 months after baseline |
| Change from Baseline in Forced Vital Capacity | Forced Vital Capacity (FVC) will be measured in liters using spirometry. | 6 and 12 months after baseline |
| Change from Baseline in Percent Predicted FEV1 | Percent Predicted Forced Expiratory Volume in 1 Second (FEV1%pred) will be calculated from spirometry and expressed as a percentage of the predicted value. | 6 and 12 months after baseline |
| Changes in Blood Pressure | Measured using a sphygmomanometer. | 3, 6, 9, and 12 months after baseline |
| Number of Participants With Abnormal Electrocardiogram Readings | Abnormal electrocardiogram (ECG) readings will be identified from standard clinical ECG reports by qualified physicians. The total number of participants with these abnormal readings will be counted. A lower number of participants with abnormal ECG readings means a better outcome (better cardiac safety profile). | 3, 6, 9, and 12 months after baseline |
| Changes in Blood Oxygen Saturation | Measured using a pulse oximeter. | 3, 6, 9, and 12 months after baseline |
| Changes in Modified Medical Research Council Score | The modified Medical Research Council (mMRC) score ranges from 0 to 4. Higher scores mean a worse outcome (more severe dyspnea). | 3, 6, 9, and 12 months after baseline |
| Changes in the COPD Assessment Test Questionnaire Score | The COPD Assessment Test (CAT) total score ranges from 0 to 40. Higher scores mean a worse outcome (a greater impact of COPD on patient's health status). | 3, 6, 9, and 12 months after baseline |
| Changes in 7-item Generalized Anxiety Disorder Questionnaire Score | The 7-item Generalized Anxiety Disorder (GAD-7) questionnaire score ranges from 0 to 21. Higher scores mean a worse outcome (more severe anxiety symptoms). | 3, 6, 9, and 12 months after baseline |
| Changes in 9-item Patient Health Questionnaire Score | The 9-item Patient Health Questionnaire (PHQ-9) score ranges from 0 to 27. Higher scores mean a worse outcome (more severe depressive symptoms). | 3, 6, 9, and 12 months after baseline |
| Changes in Environmental Temperature Risk Perception Score | Used to assess the participant's awareness and perception of health risks related to environmental temperature on the basis of the Temperature Risk Perception Questionnaire. | 3, 6, 9, and 12 months after baseline |
| Number of Participants With Abnormal Complete Blood Count Results | Abnormal complete blood count (CBC) readings will be identified from standard clinical CBC reports by qualified physicians. The total number of participants with these abnormal readings will be counted. A lower number of participants with abnormal CBC readings means a better outcome (better clinical safety profile). | 12 months after baseline |
| Frequency of Personalized Mobile Application Use | Assessed using backend data statistics from the personalized Mobile Application. | 3, 6, 9, and 12 months after baseline |
| Satisfaction with Personalized Mobile Application | Participant satisfaction with the personalized mobile application will be evaluated using the 10-item System Usability Scale (SUS). The SUS total score ranges from 0 to 100. Higher scores mean a better outcome (greater perceived usability and higher patient satisfaction with the mobile application). | 3, 6, 9, and 12 months after baseline |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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