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

N/ANot Yet RecruitingNCT07656142

Tiantian Li240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of COPD Acute Exacerbations

Total number of acute exacerbations of COPD managed at home, via outpatient visits, emergency department visits, or hospitalizations.

Time frame: 12 months after baseline

Secondary Outcomes

Number of Home-managed COPD Acute Exacerbations

Number of home-managed COPD acute exacerbations

Time frame: 6 and 12 months after baseline

Number of Outpatient-managed COPD Acute Exacerbations

Number of outpatient-managed COPD acute exacerbations

Time frame: 6 and 12 months after baseline

Number of Emergency Department-managed COPD Acute Exacerbations

Number of emergency department-managed COPD acute exacerbations

Time frame: 6 and 12 months after baseline

Number of Hospitalized COPD Acute Exacerbations

Number of hospitalized COPD acute exacerbations

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 6 and 12 months after baseline

Change from Baseline in Forced Vital Capacity

Forced Vital Capacity (FVC) will be measured in liters using spirometry.

Time frame: 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.

Time frame: 6 and 12 months after baseline

Changes in Blood Pressure

Measured using a sphygmomanometer.

Time frame: 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).

Time frame: 3, 6, 9, and 12 months after baseline

Changes in Blood Oxygen Saturation

Measured using a pulse oximeter.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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).

Time frame: 12 months after baseline

Frequency of Personalized Mobile Application Use

Assessed using backend data statistics from the personalized Mobile Application.

Time frame: 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).

Time frame: 3, 6, 9, and 12 months after baseline

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts