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

NCT07656142 | Not Yet Recruiting

• 1 other identifier: COPD-202606
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Temperature-related Health Risk; Mobile Application Intervention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (20)

• Number of Home-managed COPD Acute Exacerbations

  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

  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

  3, 6, 9, and 12 months after baseline

Study Arms (2)

Personalized Temperature Risk Intervention + Usual COPD Care

EXPERIMENTAL

Other: Mobile Application-Based Personalized Temperature Health Risk Early Warning Intervention

Usual COPD Care

NO INTERVENTION

Interventions

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.

Personalized Temperature Risk Intervention + Usual COPD Care

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Primary hospitals or private hospitals;
• Hospitals unable to cooperate with the study protocol.
• 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.

Sponsors & Collaborators

• Tiantian Li: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Can Zhang, Ph.D.

CONTACT

+8613655181384; zhangcan@nieh.chinacdc.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 18, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06