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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:
Sponsor: Chinese University of Hong Kong

Current Primary Outcome:

  • Respiratory symptoms and related physical limitation [ Time Frame: baseline ]
    examined by Hong Kong Chinese version of St. George's Respiratory Questionnaire
  • Psychological status [ Time Frame: baseline ]
    Anxiety and depression symptoms measured by the Chinese version of Hospital Anxiety and Depression Scale
  • Quality of life [ Time Frame: baseline ]
    examined by the SF-12v2
  • Social support [ Time Frame: baseline ]
    measured by the Chinese version of six-item Social Support Questionnaire
  • Body mass index [ Time Frame: baseline ]
    BMI in kg/m^2
  • waist circumference [ Time Frame: baseline ]
    WC in cm
  • 12-hour fasting lipid profile [ Time Frame: baseline ]
    total-cholesterol, HDL-Cholesterol, LDL-cholesterol and triglycerides (in mmol/L)
  • 12-hour fasting glucose [ Time Frame: baseline ]
    FG in mmol/L
  • fasting insulin level [ Time Frame: baseline ]
    insulin in pmol/L
  • 12 hour fasting ascorbic acid level [ Time Frame: baseline ]


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Chinese University of Hong Kong

    Dates:
    Date Received: May 30, 2016
    Date Started: January 2016
    Date Completion: April 2017
    Last Updated: June 5, 2016
    Last Verified: June 2016