A Personalized Mobile Application Providing Temperature-Related Health Risk Warnings and Protective Recommendations for Patients With Chronic Obstructive Pulmonary Disease

June 14, 2026 updated by: Tiantian Li

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 exclusion criteria:

  1. Patients with asthma;
  2. Women who are known to be pregnant or breastfeeding, or who have a positive pregnancy test before cluster randomization;
  3. Patients with other diseases that may affect participation in the trial, such as refractory hypertension or severe aphasia;
  4. Patients currently receiving psychiatric or psychological treatment that may contaminate study results;
  5. Expected survival time <1 year, such as in those with malignant tumors or severe cardiopulmonary disease;
  6. Participation in other interventional clinical studies that may affect outcome assessment;
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Personalized Temperature Risk Intervention + Usual COPD Care
Other: Mobile 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.
No Intervention: Usual COPD Care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of COPD Acute Exacerbations
Time Frame: 12 months after baseline
Total number of acute exacerbations of COPD managed at home, via outpatient visits, emergency department visits, or hospitalizations.
12 months after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Home-managed COPD Acute Exacerbations
Time Frame: 6 and 12 months after baseline
Number of home-managed COPD acute exacerbations
6 and 12 months after baseline
Number of Outpatient-managed COPD Acute Exacerbations
Time Frame: 6 and 12 months after baseline
Number of outpatient-managed COPD acute exacerbations
6 and 12 months after baseline
Number of Emergency Department-managed COPD Acute Exacerbations
Time Frame: 6 and 12 months after baseline
Number of emergency department-managed COPD acute exacerbations
6 and 12 months after baseline
Number of Hospitalized COPD Acute Exacerbations
Time Frame: 6 and 12 months after baseline
Number of hospitalized COPD acute exacerbations
6 and 12 months after baseline
Changes in St. George's Respiratory Questionnaire for COPD Patients Score
Time Frame: 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).
3, 6, 9, and 12 months after baseline
Changes in EuroQol 5-Dimension 5-Level Score
Time Frame: 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).
3, 6, 9, and 12 months after baseline
Change from Baseline in Forced Expiratory Volume in 1 Second
Time Frame: 6 and 12 months after baseline
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
Time Frame: 6 and 12 months after baseline
Forced Vital Capacity (FVC) will be measured in liters using spirometry.
6 and 12 months after baseline
Change from Baseline in Percent Predicted FEV1
Time Frame: 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.
6 and 12 months after baseline
Changes in Blood Pressure
Time Frame: 3, 6, 9, and 12 months after baseline
Measured using a sphygmomanometer.
3, 6, 9, and 12 months after baseline
Number of Participants With Abnormal Electrocardiogram Readings
Time Frame: 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).
3, 6, 9, and 12 months after baseline
Changes in Blood Oxygen Saturation
Time Frame: 3, 6, 9, and 12 months after baseline
Measured using a pulse oximeter.
3, 6, 9, and 12 months after baseline
Changes in Modified Medical Research Council Score
Time Frame: 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).
3, 6, 9, and 12 months after baseline
Changes in the COPD Assessment Test Questionnaire Score
Time Frame: 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).
3, 6, 9, and 12 months after baseline
Changes in 7-item Generalized Anxiety Disorder Questionnaire Score
Time Frame: 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).
3, 6, 9, and 12 months after baseline
Changes in 9-item Patient Health Questionnaire Score
Time Frame: 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).
3, 6, 9, and 12 months after baseline
Changes in Environmental Temperature Risk Perception Score
Time Frame: 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.
3, 6, 9, and 12 months after baseline
Number of Participants With Abnormal Complete Blood Count Results
Time Frame: 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).
12 months after baseline
Frequency of Personalized Mobile Application Use
Time Frame: 3, 6, 9, and 12 months after baseline
Assessed using backend data statistics from the personalized Mobile Application.
3, 6, 9, and 12 months after baseline
Satisfaction with Personalized Mobile Application
Time Frame: 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).
3, 6, 9, and 12 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tiantian Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COPD-202606

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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