Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD

Sponsor

Asan Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04878367

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is a prospective, multi-institutional clinical study and targets patients diagnosed with chronic obstructive pulmonary disease. About 120 subjects (35 at Ilsan Paik Hospital, 35 at Severance Hospital, and 50 at Asan Medical Center in Seoul) will be subject to a random allocation of 1:1. The arbitration group implements living rules for responding to fine dust, supports air purifiers, and only general guidance is implemented in the non-property group. Patients are recruited from Asan Medical Center in Seoul (Songpa-gu, Seoul), Severance Hospital ( Seodaemun-gu, Seoul), and Ilsan Paik Medical Center (Goyang, Gyeonggi-do) for 12 months. During outpatient visits, lung function tests and airway resistance tests shall be conducted, and surveys presented in the research plan shall be conducted.

Condition or Disease	Intervention/Treatment	Phase
COPD	Behavioral: Five active practices of living rules for responding to fine dust.	N/A

Detailed Description

It is a prospective and multi-institutional clinical study targeting patients with chronic obstructive pulmonary disease in general.

A total of 120 COPD patients will be recruited from three institutions: Asan Medical Center, Severance Hospital, and Ilsan Paik Hospital. (60/30/30 expected) A panel of COPD patients is established to conduct prospective studies, and measures to mediate recurrence and deterioration of adult chronic respiratory diseases due to exposure to fine dust are presented. Improvement of the lifestyle of the arbitration forces. Detailed research methods such as air purifier support are presented in the research plan.

In addition, a fine dust measurement researcher visits each household to measure indoor fine dust concentration. The measurement method of fine dust concentration will be using the process test method, IoT-based sensors, and direct-to-read measuring devices to measure Air Korea's air pollution. Detailed visit timing and methods are carried out in the manner specified in the research plan.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

COPD without intervention group , with intervention groupCOPD without intervention group , with intervention group

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COPD_E COPD patients with intervention	Behavioral: Five active practices of living rules for responding to fine dust. Check the fine dust weather forecast Check the operation time and filter of the air purifier Window ventilation Inhalant is used or not Bad fine dust: Refrain from going out
No Intervention: COPD_C COPD patients without intervention

Arm

Intervention/Treatment

Experimental: COPD_E

COPD patients with intervention

Behavioral: Five active practices of living rules for responding to fine dust.

Check the fine dust weather forecast Check the operation time and filter of the air purifier Window ventilation Inhalant is used or not Bad fine dust: Refrain from going out

No Intervention: COPD_C

COPD patients without intervention

Outcome Measures

Primary Outcome Measures

pulmonary function test (FEV1/FVC) % [12 months]
pulmonary function test (FEV1/FVC) %

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

40 years of age or older
Waste function test results show FEV1/FVC<0.7, FEV1 <80% of forecast

Exclusion Criteria:

Patients under 18 years of age with changes in medication (such as inhalants).
Older people over 80 years of age.
People with no respiratory symptoms with mMRC 0.
Who doesn't understand a simple explanation for fine dust exposure devices.
Someone who disagrees with the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of	05505

Sponsors and Collaborators

Asan Medical Center

Investigators

Principal Investigator: Sei won Lee, Seoul Asan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sei Won Lee, associate professor, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT04878367

Other Study ID Numbers:

2021-0956

First Posted:

May 7, 2021

Last Update Posted:

Dec 7, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 7, 2021