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Evaluating the Relationship Between Environmental Risk Factors in Housing Types and Chronic Respiratory Diseases in Ho Chi Minh City

Primary Purpose

Chronic Respiratory Diseases

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Questionnaire
Lung function test
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Chronic Respiratory Diseases focused on measuring chronic respiratory diseases, housing, lung function test

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Everybody

Exclusion Criteria:

  • Not able to answer the questionnaire or give informed consent
  • Have a contra-indication for lung function test (acute myocardial infarction less that 1 month ago, pain related to spirometry, dementia/confused)

Sites / Locations

  • Pham Ngoc Thach University of medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Tube houses

Apartment

Rental Houses

Rural houses

Arm Description

Tube Houses. Group of 75-100 houses, with 4 inhabitants per house. Expected number of participants: 300-400. Predicted number of non-smoker chronic respiratory disease of 18-24.

Apartments. Group of 75-100 apartments, with 4 inhabitants per apartment. Expected number of participants: 300-400. Predicted number of non-smoker chronic respiratory disease of 18-24.

Rental Houses. Group of 150-200 rental houses, with 2 inhabitants per rental house. Expected number of participants: 300-400. Predicted number of non-smoker chronic respiratory disease of 18-24.

Rural Houses. Group of 40-60 rural houses, with 5 inhabitant per rural house. Expected number of participants: 200-300. Predicted number of non-smoker chronic respiratory disease of 12-18.

Outcomes

Primary Outcome Measures

FEV1/FVC
Basic lung function test, without broncho dilatation (micro-spirometer). All lung function related outcomes are performed during the same test. FEV1: forced expiratory volume in one second. FVC: Forced vital capacity.
FVC
Basic lung function test, without broncho dilatation (micro-spirometer). All lung function related outcomes are performed during the same test.FVC: Forced vital capacity.
VC
Basic lung function test, without broncho dilatation (micro-spirometer). All lung function related outcomes performed during the same test. VC: Vital capacity
FEF 25-75%
Basic lung function test, without broncho dilatation (micro-spirometer).All lung function related outcomes are performed during the same test. FEF: Forced expiratory flow
Socio-demographic status
Socio-demographic data, assessed by a home made questionnaire
Health status
Health status (symptomatology) data, assessed by a home made questionnaire
Indoor air exposure time
Indoor air exposure (time spent indoor within housing types, with associated air characteristics) data, assessed by a home made questionnaire

Secondary Outcome Measures

Full Information

First Posted
September 8, 2016
Last Updated
August 3, 2017
Sponsor
Brugmann University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02898129
Brief Title
Evaluating the Relationship Between Environmental Risk Factors in Housing Types and Chronic Respiratory Diseases in Ho Chi Minh City
Official Title
Evaluating the Relationship Between Environmental Risk Factors in Housing Types and Chronic Respiratory Diseases in Ho Chi Minh City
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The research question is "Are the different types of house in Ho Chi Minh city equally contributing to chronic respiratory diseases?". According to this question, a cross-sectional and explorative study was set up to explore the differences in the environmental characteristics and prevalence of chronic respiratory diseases among common housing types in Ho Chi Minh city. Preliminary work was performed in 100 houses (20 houses per type, included tube houses, rental houses, rural houses, slum and apartment) from November 2013 to June 2015. It included measures by environmental devices, questionnaires and indoor activities diaries. This study will aim to collect information about the prevalence of chronic respiratory diseases (CRDs) inside those house types to understand more about role of house types in developing CRDs. The objective is: to evaluate the relationships between the type of house and lung function of inhabitants in each housing type. to evaluate the effects of environmental risk factors in each house type on prevalence of CRDs

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Diseases
Keywords
chronic respiratory diseases, housing, lung function test

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tube houses
Arm Type
Experimental
Arm Description
Tube Houses. Group of 75-100 houses, with 4 inhabitants per house. Expected number of participants: 300-400. Predicted number of non-smoker chronic respiratory disease of 18-24.
Arm Title
Apartment
Arm Type
Experimental
Arm Description
Apartments. Group of 75-100 apartments, with 4 inhabitants per apartment. Expected number of participants: 300-400. Predicted number of non-smoker chronic respiratory disease of 18-24.
Arm Title
Rental Houses
Arm Type
Experimental
Arm Description
Rental Houses. Group of 150-200 rental houses, with 2 inhabitants per rental house. Expected number of participants: 300-400. Predicted number of non-smoker chronic respiratory disease of 18-24.
Arm Title
Rural houses
Arm Type
Experimental
Arm Description
Rural Houses. Group of 40-60 rural houses, with 5 inhabitant per rural house. Expected number of participants: 200-300. Predicted number of non-smoker chronic respiratory disease of 12-18.
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Type
Device
Intervention Name(s)
Lung function test
Intervention Description
Basic lung function test performed with a micro-spirometer, without broncho dilatator
Primary Outcome Measure Information:
Title
FEV1/FVC
Description
Basic lung function test, without broncho dilatation (micro-spirometer). All lung function related outcomes are performed during the same test. FEV1: forced expiratory volume in one second. FVC: Forced vital capacity.
Time Frame
5 minutes
Title
FVC
Description
Basic lung function test, without broncho dilatation (micro-spirometer). All lung function related outcomes are performed during the same test.FVC: Forced vital capacity.
Time Frame
5 minutes
Title
VC
Description
Basic lung function test, without broncho dilatation (micro-spirometer). All lung function related outcomes performed during the same test. VC: Vital capacity
Time Frame
5 minutes
Title
FEF 25-75%
Description
Basic lung function test, without broncho dilatation (micro-spirometer).All lung function related outcomes are performed during the same test. FEF: Forced expiratory flow
Time Frame
5 minutes
Title
Socio-demographic status
Description
Socio-demographic data, assessed by a home made questionnaire
Time Frame
around 10 minutes
Title
Health status
Description
Health status (symptomatology) data, assessed by a home made questionnaire
Time Frame
around 10 minutes
Title
Indoor air exposure time
Description
Indoor air exposure (time spent indoor within housing types, with associated air characteristics) data, assessed by a home made questionnaire
Time Frame
around 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Everybody Exclusion Criteria: Not able to answer the questionnaire or give informed consent Have a contra-indication for lung function test (acute myocardial infarction less that 1 month ago, pain related to spirometry, dementia/confused)
Facility Information:
Facility Name
Pham Ngoc Thach University of medicine
City
Ho Chi Minh City
ZIP/Postal Code
7000
Country
Vietnam

12. IPD Sharing Statement

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Evaluating the Relationship Between Environmental Risk Factors in Housing Types and Chronic Respiratory Diseases in Ho Chi Minh City

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