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

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.

Study Overview

• Status: Completed
• Conditions: Silicosis
• Intervention / Treatment: Other: People with silicosis

• Study Type: Observational
• Enrollment (Actual): 390

Contacts and Locations

Study Locations

• China
  • Hong Kong SAR, China
    • The Nethersole School of Nursing, Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A convenience sample of 390 eligible participants registered with the Pneumoconiosis Compensation Fund Board will be recruited with stratification by their degree of incapacity [(i) <30%, (ii) 30% - 60%, and (iii) >60%], in which the minimal number of participants in each strata will be 30.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
people with silicosis	Other: People with silicosis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Ho Yu CHENG, PhD, RN, The Nethersole School of Nursing, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 5, 2016
• First Posted (Estimate): June 9, 2016

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Occupational Diseases; Pneumoconiosis; Lung Diseases, Interstitial; Lung Injury; Silicosis
• Other Study ID Numbers: CRE-2015.499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO