Comprehensive Risk Assessment of People With Silicosis: A Population-based Study

Silicosis Clinical Trial

Official title:

Comprehensive Risk Assessment of People With Silicosis: A Population-based Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794701
• Other study ID #: CRE-2015.499
• Status: Completed
• Start date: June 2016
• Est. completion date: April 2017

Study information

• Verified date: July 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Objectives: This study aims to explore the risk profiles among people with silicosis in Hong Kong underpinned by the Pittsburgh Mind-Body Center model.

Design and subjects: This study will adopt a cross-sectional study design with sampling stratified by participants' degree of incapability. 320 Chinese people diagnosed with silicosis and registered with the Pneumoconiosis Compensation Fund Board will be recruited.

Data collection: A demographic data sheet and the St. George's Respiratory Questionnaire will be used to collect the socio-demographic and clinical characteristics of the participants. The behavioral factors (smoking, drinking, physical activity level, consumption of vegetable and fruits and plasma vitamin C level) as well as the psychological risk factors (anxiety and depressive symptoms, and social support) will be examined by validated questionnaires. Biological and physiological parameters, including insulin resistance, C-reactive protein, hemoglobin, fasting blood glucose and lipid profiles, will be ascertained by fasting blood sample.

Data analysis and expected outcomes: The findings of this study will create the database profile of the physical, psychosocial and disease specific aspects among people with silicosis in Hong Kong, subsequently forming the empirical basis of an intervention to tackle the identified modifiable risks among them.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hong Kong Chinese-speaking residents and Chinese ethnicity;

• diagnosis of silicosis and confirmed by the Pneumoconiosis Medical Board

• registered with the Pneumoconiosis Compensation Fund Board (PCFB); and

• able and willing to give informed written consent

Exclusion Criteria:

• With medically diagnosed mental illness, including major depression, or

• with active pulmonary tuberculosis

Related Conditions & MeSH terms

• Silicosis

Intervention

Other:
• People with silicosis

Locations

Country	Name	City	State
China	The Nethersole School of Nursing, Chinese University of Hong Kong	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory symptoms and related physical limitation	examined by Hong Kong Chinese version of St. George's Respiratory Questionnaire	baseline
Primary	Psychological status	Anxiety and depression symptoms measured by the Chinese version of Hospital Anxiety and Depression Scale	baseline
Primary	Quality of life	examined by the SF-12v2	baseline
Primary	Social support	measured by the Chinese version of six-item Social Support Questionnaire	baseline
Primary	Body mass index	BMI in kg/m^2	baseline
Primary	waist circumference	WC in cm	baseline
Primary	12-hour fasting lipid profile	total-cholesterol, HDL-Cholesterol, LDL-cholesterol and triglycerides (in mmol/L)	baseline
Primary	12-hour fasting glucose	FG in mmol/L	baseline
Primary	fasting insulin level	insulin in pmol/L	baseline
Primary	12 hour fasting ascorbic acid level	vit-C in mg/dL	baseline
Primary	fasting high sensitivity C-reactive protein level	hs-CRP in mg/L	baseline
Primary	hemoglobin level	hemoglobin in g/dL	baseline
Primary	smoking and drinking habits, vegetable and fruit intake	questions adopted from the Behavioral Risk Factor Surveillance of the Department of Health, Hong Kong SAR	baseline
Primary	Physical activity level	measured by the International Physical Activity Questionnaire - Short Form	baseline