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

Completed

• Conditions: Silicosis
• Interventions: Other: People with silicosis

• Registration Number: NCT02794701
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-30
• Study Start: 2016-06
• Study First Submitted QC: 2016-06-05
• Study First Posted: 2016-06-09
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-05
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

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

Read More

Exclusion Criteria

• With medically diagnosed mental illness, including major depression, or
• with active pulmonary tuberculosis

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
people with silicosis	People with silicosis	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Nethersole School of Nursing, Chinese University of Hong Kong; 🇨🇳 Hong Kong SAR, China