A Personalized Mobile Application Providing Temperature-Related Health Risk Warnings and Protective Recommendations for Patients With Chronic Obstructive Pulmonary Disease
14. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
240
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Can Zhang, Ph.D.
- Telefonní číslo: +8613655181384
- E-mail: zhangcan@nieh.chinacdc.cn
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Personalized Temperature Risk Intervention + Usual COPD Care
|
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.
|
|
Žádný zásah: Usual COPD Care
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of COPD Acute Exacerbations
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Home-managed COPD Acute Exacerbations
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. června 2026
Primární dokončení (Odhadovaný)
1. srpna 2027
Dokončení studie (Odhadovaný)
1. srpna 2027
Termíny zápisu do studia
První předloženo
9. června 2026
První předloženo, které splnilo kritéria kontroly kvality
14. června 2026
První zveřejněno (Aktuální)
18. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
14. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- COPD-202606
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Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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