Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794701
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ho Yu CHENG, 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.


Condition or disease Intervention/treatment
Silicosis Other: People with silicosis

Layout table for study information
Study Type : Observational
Actual Enrollment : 390 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Comprehensive Risk Assessment of People With Silicosis: A Population-based Study
Actual Study Start Date : June 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794701


Locations
Layout table for location information
China
The Nethersole School of Nursing, Chinese University of Hong Kong
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Ho Yu CHENG, PhD, RN The Nethersole School of Nursing, Chinese University of Hong Kong
Layout table for additonal information
Responsible Party: Ho Yu CHENG, post-doctoral fellow, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02794701    
Other Study ID Numbers: CRE-2015.499
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Silicosis
Pneumoconiosis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Occupational Diseases