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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02794701
Enrollment
390
Registered
2016-06-09
Start date
2016-06-30
Completion date
2017-04-30
Last updated
2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Silicosis

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.

Interventions

OTHERPeople with silicosis

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory symptoms and related physical limitationbaselineexamined by Hong Kong Chinese version of St. George's Respiratory Questionnaire
Psychological statusbaselineAnxiety and depression symptoms measured by the Chinese version of Hospital Anxiety and Depression Scale
Quality of lifebaselineexamined by the SF-12v2
Social supportbaselinemeasured by the Chinese version of six-item Social Support Questionnaire
Body mass indexbaselineBMI in kg/m\^2
waist circumferencebaselineWC in cm
12-hour fasting lipid profilebaselinetotal-cholesterol, HDL-Cholesterol, LDL-cholesterol and triglycerides (in mmol/L)
12-hour fasting glucosebaselineFG in mmol/L
fasting insulin levelbaselineinsulin in pmol/L
12 hour fasting ascorbic acid levelbaselinevit-C in mg/dL
fasting high sensitivity C-reactive protein levelbaselinehs-CRP in mg/L
hemoglobin levelbaselinehemoglobin in g/dL
smoking and drinking habits, vegetable and fruit intakebaselinequestions adopted from the Behavioral Risk Factor Surveillance of the Department of Health, Hong Kong SAR
Physical activity levelbaselinemeasured by the International Physical Activity Questionnaire - Short Form

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026