Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD

NCT ID: NCT04878367

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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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.

We collect sputum at every visit and blood at the last visit.

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

COPD without intervention group , with intervention group
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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COPD_E

COPD patients with intervention

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

COPD_C

COPD patients without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sei Won Lee

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sei won Lee

Role: PRINCIPAL_INVESTIGATOR

Seoul Asan Hospital

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Ji HW, Kang J, Kim HC, Jung J, Lee SJ, Jung JY, Lee SW. The association between cumulative exposure to PM2.5 and DNA methylation measured using methyl-capture sequencing among COPD patients. Respir Res. 2024 Sep 9;25(1):335. doi: 10.1186/s12931-024-02955-3.

Reference Type DERIVED
PMID: 39251997 (View on PubMed)

Kang J, Kim HC, Jang Y, Lee JB, Lee JS, Oh YM, Ji HW, Jung JY, Lee SW. Randomised controlled trial of a behavioural intervention to reduce exposure to PM2.5 in patients with COPD. Environ Int. 2023 Nov;181:108286. doi: 10.1016/j.envint.2023.108286. Epub 2023 Oct 24.

Reference Type DERIVED
PMID: 37918066 (View on PubMed)

Kang J, Jung JY, Huh JY, Ji HW, Kim HC, Lee SW. Behavioral interventions to reduce particulate matter exposure in patients with COPD. Medicine (Baltimore). 2021 Dec 10;100(49):e28119. doi: 10.1097/MD.0000000000028119.

Reference Type DERIVED
PMID: 34889270 (View on PubMed)

Other Identifiers

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2021-0956

Identifier Type: -

Identifier Source: org_study_id

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