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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT02794701
Collaborator
(none)
390
1
10
39

Study Details

Study Description

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 Phase
  • Other: People with silicosis

Study Design

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 :
Jun 1, 2016
Actual Primary Completion Date :
Apr 1, 2017
Actual Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
people with silicosis

Other: People with silicosis

Outcome Measures

Primary Outcome Measures

  1. Respiratory symptoms and related physical limitation [baseline]

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

  2. Psychological status [baseline]

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

  3. Quality of life [baseline]

    examined by the SF-12v2

  4. Social support [baseline]

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

  5. Body mass index [baseline]

    BMI in kg/m^2

  6. waist circumference [baseline]

    WC in cm

  7. 12-hour fasting lipid profile [baseline]

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

  8. 12-hour fasting glucose [baseline]

    FG in mmol/L

  9. fasting insulin level [baseline]

    insulin in pmol/L

  10. 12 hour fasting ascorbic acid level [baseline]

    vit-C in mg/dL

  11. fasting high sensitivity C-reactive protein level [baseline]

    hs-CRP in mg/L

  12. hemoglobin level [baseline]

    hemoglobin in g/dL

  13. smoking and drinking habits, vegetable and fruit intake [baseline]

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

  14. Physical activity level [baseline]

    measured by the International Physical Activity Questionnaire - Short Form

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Nethersole School of Nursing, Chinese University of Hong Kong Hong Kong SAR China

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jun 9, 2016
Last Update Posted:
Jul 6, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2018