Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Temperature-related Health Risk, Mobile Application Intervention
Brief summary
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.
Detailed description
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.
Interventions
OTHERMobile Application-Based Personalized Temperature Health Risk Early Warning Intervention
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.
Sponsors
Tiantian Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Hospital inclusion criteria: 1. Tertiary hospitals; 2. Hospitals with respiratory wards that admit patients with COPD; 3. Hospitals with a well-established electronic health record system and follow-up capability; 4. Hospitals able to assign a study coordinator. Patient inclusion criteria: 1. Age \>=40 years and \<=80 years, with no restriction on sex; 2. Patients with stable chronic obstructive pulmonary disease; 3. At least 1 severe acute exacerbation requiring hospitalization, or at least 2 moderate acute exacerbations requiring outpatient or emergency care, within the previous year; 4. Local permanent residents with a duration of residence \>=6 months; 5. Patients who voluntarily agree to participate, are expected to have good adherence, are able to sign informed consent; 6. Patients who own a smartphone or other smart device. Hospital
Exclusion criteria
1. Primary hospitals or private hospitals; 2. Hospitals unable to cooperate with the study protocol. Patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of COPD Acute Exacerbations | 12 months after baseline | Total number of acute exacerbations of COPD managed at home, via outpatient visits, emergency department visits, or hospitalizations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Home-managed COPD Acute Exacerbations | 6 and 12 months after baseline | Number of home-managed COPD acute exacerbations |
| Number of Outpatient-managed COPD Acute Exacerbations | 6 and 12 months after baseline | Number of outpatient-managed COPD acute exacerbations |
| Number of Emergency Department-managed COPD Acute Exacerbations | 6 and 12 months after baseline | Number of emergency department-managed COPD acute exacerbations |
| Number of Hospitalized COPD Acute Exacerbations | 6 and 12 months after baseline | Number of hospitalized COPD acute exacerbations |
| Changes in St. George's Respiratory Questionnaire for COPD Patients Score | 3, 6, 9, and 12 months after baseline | 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). |
| Changes in EuroQol 5-Dimension 5-Level Score | 3, 6, 9, and 12 months after baseline | 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). |
| Change from Baseline in Forced Expiratory Volume in 1 Second | 6 and 12 months after baseline | Forced Expiratory Volume in 1 Second (FEV1) will be measured in liters using spirometry. |
| Change from Baseline in Forced Vital Capacity | 6 and 12 months after baseline | Forced Vital Capacity (FVC) will be measured in liters using spirometry. |
| Change from Baseline in Percent Predicted FEV1 | 6 and 12 months after baseline | Percent Predicted Forced Expiratory Volume in 1 Second (FEV1%pred) will be calculated from spirometry and expressed as a percentage of the predicted value. |
| Changes in Blood Pressure | 3, 6, 9, and 12 months after baseline | Measured using a sphygmomanometer. |
| Number of Participants With Abnormal Electrocardiogram Readings | 3, 6, 9, and 12 months after baseline | 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). |
| Changes in Blood Oxygen Saturation | 3, 6, 9, and 12 months after baseline | Measured using a pulse oximeter. |
| Changes in Modified Medical Research Council Score | 3, 6, 9, and 12 months after baseline | The modified Medical Research Council (mMRC) score ranges from 0 to 4. Higher scores mean a worse outcome (more severe dyspnea). |
| Changes in the COPD Assessment Test Questionnaire Score | 3, 6, 9, and 12 months after baseline | 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). |
| Changes in 7-item Generalized Anxiety Disorder Questionnaire Score | 3, 6, 9, and 12 months after baseline | 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). |
| Changes in 9-item Patient Health Questionnaire Score | 3, 6, 9, and 12 months after baseline | The 9-item Patient Health Questionnaire (PHQ-9) score ranges from 0 to 27. Higher scores mean a worse outcome (more severe depressive symptoms). |
| Changes in Environmental Temperature Risk Perception Score | 3, 6, 9, and 12 months after baseline | 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. |
| Number of Participants With Abnormal Complete Blood Count Results | 12 months after baseline | 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). |
| Frequency of Personalized Mobile Application Use | 3, 6, 9, and 12 months after baseline | Assessed using backend data statistics from the personalized Mobile Application. |
| Satisfaction with Personalized Mobile Application | 3, 6, 9, and 12 months after baseline | 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). |
Contacts
CONTACTCan Zhang, Ph.D.
Outcome results
None listed