Skip to main content
OpenTrials
Completed

NCT Number: NCT02794701

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Silicosis Lung Diseases Lung Diseases, Interstitial Lung Injury Occupational Diseases Pneumoconiosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Nethersole School of Nursing, Chinese University of Hong Kong

Hong Kong SAR, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

People with silicosis

Other

Primary outcomes

  1. Respiratory symptoms and related physical limitation

    Time frame: baseline

    examined by Hong Kong Chinese version of St. George's Respiratory Questionnaire

  2. Psychological status

    Time frame: baseline

    Anxiety and depression symptoms measured by the Chinese version of Hospital Anxiety and Depression Scale

  3. Quality of life

    Time frame: baseline

    examined by the SF-12v2

  4. Social support

    Time frame: baseline

    measured by the Chinese version of six-item Social Support Questionnaire

  5. Body mass index

    Time frame: baseline

    BMI in kg/m^2

  6. waist circumference

    Time frame: baseline

    WC in cm

  7. 12-hour fasting lipid profile

    Time frame: baseline

    total-cholesterol, HDL-Cholesterol, LDL-cholesterol and triglycerides (in mmol/L)

  8. 12-hour fasting glucose

    Time frame: baseline

    FG in mmol/L

  9. fasting insulin level

    Time frame: baseline

    insulin in pmol/L

  10. 12 hour fasting ascorbic acid level

    Time frame: baseline

    vit-C in mg/dL

  11. fasting high sensitivity C-reactive protein level

    Time frame: baseline

    hs-CRP in mg/L

  12. hemoglobin level

    Time frame: baseline

    hemoglobin in g/dL

  13. smoking and drinking habits, vegetable and fruit intake

    Time frame: baseline

    questions adopted from the Behavioral Risk Factor Surveillance of the Department of Health, Hong Kong SAR

  14. Physical activity level

    Time frame: baseline

    measured by the International Physical Activity Questionnaire - Short Form

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2016
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.