Chronic Obstructive Pulmonary DiseaseNCT07656142
A Personalized Mobile Application Providing Temperature-Related Health Risk Warnings and Protective Recommendations for Patients With Chronic Obstructive Pulmonary Disease
A study testing Mobile Application-Based Personalized Temperature Health Risk Early Warning Intervention in people with Chronic Obstructive Pulmonary Disease, run by Tiantian Li at 4 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Mobile Application-Based Personalized Temperature Health Risk Early Warning Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesChina
- Study dates
- 4 Aug 2026to Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Hospital inclusion criteria:
- Tertiary hospitals;
- Hospitals with respiratory wards that admit patients with COPD;
- Hospitals with a well-established electronic health record system and follow-up capability;
- Hospitals able to assign a study coordinator.
Patient inclusion criteria:
- Age >=40 years and <=80 years, with no restriction on sex;
- Patients with stable chronic obstructive pulmonary disease;
- At least 1 severe acute exacerbation requiring hospitalization, or at least 2 moderate acute exacerbations requiring outpatient or emergency care, within the previous year;
- Local permanent residents with a duration of residence >=6 months;
- Patients who voluntarily agree to participate, are expected to have good adherence, are able to sign informed consent;
- Patients who own a smartphone or other smart device.
Hospital exclusion criteria:
- Primary hospitals or private hospitals;
- Hospitals unable to cooperate with the study protocol.
Patient exclusion criteria:
- Patients with asthma;
- Women who are known to be pregnant or breastfeeding, or who have a positive pregnancy test before cluster randomization;
- Patients with other diseases that may affect participation in the trial, such as refractory hypertension or severe aphasia;
- Patients currently receiving psychiatric or psychological treatment that may contaminate study results;
- Expected survival time <1 year, such as in those with malignant tumors or severe cardiopulmonary disease;
- Participation in other interventional clinical studies that may affect outcome assessment;
- Any other circumstances in which the investigator considers the patient unsuitable for participation in this study or at significant risk, such as cognitive impairment preventing understanding of and/or compliance with study procedures and/or follow-up.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing
Can Zhang, +8613655181384, zhangcan@nieh.chinacdc.cn
- Recruiting
Beijing Huairou Hospital
Beijing
Can Zhang, +8613655181384, zhangcan@nieh.chinacdc.cn
- Recruiting
Civil Aviation General Hospital
Beijing
Can Zhang, +8613655181384, zhangcan@nieh.chinacdc.cn
- Recruiting
Emergency General Hospital
Beijing
Can Zhang, +8613655181384, zhangcan@nieh.chinacdc.cn
About this study
Official title: Effectiveness of A Personalized Mobile Application Providing Temperature-Related Health Risk Warnings and Protective Recommendations for Patients With Chronic Obstructive Pulmonary Disease
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Mobile Application-Based Personalized Temperature Health Risk Early Warning Intervention
- Keywords
- COPD, Temperature-related Health Risk, Mobile Application Intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application-Based Personalized Temperature Health Risk Early Warning InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Temperature Risk Intervention + Usual COPD Care | Experimental | Not described Receives: Other: Mobile Application-Based Personalized Temperature Health Risk Early Warning Intervention |
| Usual COPD Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of COPD Acute Exacerbations
Total number of acute exacerbations of COPD managed at home, via outpatient visits, emergency department visits, or hospitalizations.
Measured: 12 months after baseline
Secondary outcomes (20)
Number of Home-managed COPD Acute Exacerbations
Number of home-managed COPD acute exacerbations
Measured: 6 and 12 months after baseline
Number of Outpatient-managed COPD Acute Exacerbations
Number of outpatient-managed COPD acute exacerbations
Measured: 6 and 12 months after baseline
Number of Emergency Department-managed COPD Acute Exacerbations
Number of emergency department-managed COPD acute exacerbations
Measured: 6 and 12 months after baseline
Number of Hospitalized COPD Acute Exacerbations
Number of hospitalized COPD acute exacerbations
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 6 and 12 months after baseline
Change from Baseline in Forced Vital Capacity
Forced Vital Capacity (FVC) will be measured in liters using spirometry.
Measured: 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.
Measured: 6 and 12 months after baseline
Changes in Blood Pressure
Measured using a sphygmomanometer.
Measured: 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).
Measured: 3, 6, 9, and 12 months after baseline
Changes in Blood Oxygen Saturation
Measured using a pulse oximeter.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 12 months after baseline
Frequency of Personalized Mobile Application Use
Assessed using backend data statistics from the personalized Mobile Application.
Measured: 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).
Measured: 3, 6, 9, and 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start4 Aug 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tiantian Li
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Tiantian Li, Centers for Disease Control and Prevention, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656142
- Sponsor's protocol ID
- COPD-202606
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No