NCT02898129

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:

  1. 1.to evaluate the relationships between the type of house and lung function of inhabitants in each housing type.
  2. 2.to evaluate the effects of environmental risk factors in each house type on prevalence of CRDs

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

September 8, 2016

Last Update Submit

August 3, 2017

Conditions

Keywords

chronic respiratory diseaseshousinglung function test

Outcome Measures

Primary Outcomes (7)

  • 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.

    5 minutes

  • 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.

    5 minutes

  • VC

    Basic lung function test, without broncho dilatation (micro-spirometer). All lung function related outcomes performed during the same test. VC: Vital capacity

    5 minutes

  • 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

    5 minutes

  • Socio-demographic status

    Socio-demographic data, assessed by a home made questionnaire

    around 10 minutes

  • Health status

    Health status (symptomatology) data, assessed by a home made questionnaire

    around 10 minutes

  • Indoor air exposure time

    Indoor air exposure (time spent indoor within housing types, with associated air characteristics) data, assessed by a home made questionnaire

    around 10 minutes

Study Arms (4)

Tube houses

EXPERIMENTAL

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.

Other: QuestionnaireDevice: Lung function test

Apartment

EXPERIMENTAL

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.

Other: QuestionnaireDevice: Lung function test

Rental Houses

EXPERIMENTAL

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.

Other: QuestionnaireDevice: Lung function test

Rural houses

EXPERIMENTAL

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.

Other: QuestionnaireDevice: Lung function test

Interventions

ApartmentRental HousesRural housesTube houses

Basic lung function test performed with a micro-spirometer, without broncho dilatator

ApartmentRental HousesRural housesTube houses

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Everybody

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pham Ngoc Thach University of medicine

Ho Chi Minh City, 7000, Vietnam

Location

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MeSH Terms

Interventions

Surveys and QuestionnairesRespiratory Function Tests

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 13, 2016

Study Start

September 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 4, 2017

Record last verified: 2017-08

Locations