Real Time Early Warning Model and Mobile Medical Assistan... | NCT04960410

Studies
Real Time Early Warning Model and Mobile Medical Assistant System for the Impact of Air Pollution on AECOPD Disease

NCT04960410

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Jul 13, 2021Actual

Enrollment

56Actual

Phase

Not provided

Conditions

COPD

Interventions

Types and exposure of different air pollutants

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Apr 23, 2017Actual

Completion Date

Dec 30, 2018Actual

First Submitted Date

Jul 4, 2021

First Submission Date that Met QC Criteria

Jul 4, 2021

First Posted Date

Jul 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2021

Last Update Posted Date

Jul 13, 2021Actual

Name	Class
Beihang University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (COPD) caused by air pollution, and develop the corresponding mobile medical assistant system. Through the cross fusion of existing information technology and medical research results, an auxiliary medical system is formed for information recording, tracking tools, early warning model and clinical diagnosis of patients with COPD.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low air pollution			Combination Product: Types and exposure of different air pollutants
High air pollution			Combination Product: Types and exposure of different air pollutants

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Types and exposure of different air pollutants	Combination Product	Types and exposure of different air pollutants in COPD patients' living and working environment	High air pollution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of acute exacerbations	Frequency of acute exacerbations	1 year incidence rate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged > 40 and < 80 years with post-bronchodilator FEV1/ forced vital capacity (FVC) < 0.7 and percentage predicted of FEV1>30%, who were no exacerbation of symptoms in the 6 weeks preceding the study, were included in the study.

Exclusion Criteria:

Patients who were diagnosed with other chronic respiratory diseases, including bronchial asthma, bronchiectasis and lung abscess.
Patients with near-terminal illness, congestive heart failure (NYHA III-IV), or cannot record CAT score timely were excluded.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Stable chronic obstructive pulmonary disease (COPD) patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yahong Chen, Dr.	Peking University Third Hospital	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided