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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Number of COPD Acute Exacerbations [Срок оценки: 12 months after baseline]

Вторичные конечные точки (12)

• Number of Home-managed COPD Acute Exacerbations [Срок оценки: 6 and 12 months after baseline]
• Number of Outpatient-managed COPD Acute Exacerbations [Срок оценки: 6 and 12 months after baseline]
• Number of Emergency Department-managed COPD Acute Exacerbations [Срок оценки: 6 and 12 months after baseline]
• Number of Hospitalized COPD Acute Exacerbations [Срок оценки: 6 and 12 months after baseline]
• Changes in St. George's Respiratory Questionnaire for COPD Patients Score [Срок оценки: 3, 6, 9, and 12 months after baseline]
• Changes in EuroQol 5-Dimension 5-Level Score [Срок оценки: 3, 6, 9, and 12 months after baseline]
• Change from Baseline in Forced Expiratory Volume in 1 Second [Срок оценки: 6 and 12 months after baseline]
• Change from Baseline in Forced Vital Capacity [Срок оценки: 6 and 12 months after baseline]
• Change from Baseline in Percent Predicted FEV1 [Срок оценки: 6 and 12 months after baseline]
• Changes in Blood Pressure [Срок оценки: 3, 6, 9, and 12 months after baseline]
• Number of Participants With Abnormal Electrocardiogram Readings [Срок оценки: 3, 6, 9, and 12 months after baseline]
• Changes in Blood Oxygen Saturation [Срок оценки: 3, 6, 9, and 12 months after baseline]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07656142 · COPD-202606

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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