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CompletedNCT02794701Updated Jul 6, 2018

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

An observational study in Silicosis, sponsored by Chinese University of Hong Kong. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-06.

Sponsored by Chinese University of Hong Kong · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
390
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Silicosis

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03

In context

Silicosis

20 studies on the registry are indexed under Silicosis; 3 are open to participants now.

This study's enrollment of 390 is above the median of 150 across 11 observational studies indexed under Silicosis.

Browse Silicosis studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • With medically diagnosed mental illness, including major depression, or
  • with active pulmonary tuberculosis
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
390 participants (actual)
Patient registry
No

Groups and cohorts

  • people with silicosis

    Other: People with silicosis

Interventions

  • OtherPeople with silicosis
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What researchers measure

Primary outcomes

  1. Respiratory symptoms and related physical limitation

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

    Time frame: baseline

  2. Psychological status

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

    Time frame: baseline

  3. Quality of life

    examined by the SF-12v2

    Time frame: baseline

  4. Social support

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

    Time frame: baseline

  5. Body mass index

    BMI in kg/m\^2

    Time frame: baseline

  6. waist circumference

    WC in cm

    Time frame: baseline

  7. 12-hour fasting lipid profile

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

    Time frame: baseline

  8. 12-hour fasting glucose

    FG in mmol/L

    Time frame: baseline

  9. fasting insulin level

    insulin in pmol/L

    Time frame: baseline

  10. 12 hour fasting ascorbic acid level

    vit-C in mg/dL

    Time frame: baseline

  11. fasting high sensitivity C-reactive protein level

    hs-CRP in mg/L

    Time frame: baseline

  12. hemoglobin level

    hemoglobin in g/dL

    Time frame: baseline

  13. smoking and drinking habits, vegetable and fruit intake

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

    Time frame: baseline

  14. Physical activity level

    measured by the International Physical Activity Questionnaire - Short Form

    Time frame: baseline

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Study locations

1 site
  • The Nethersole School of Nursing, Chinese University of Hong Kong
    Hong Kong SAR, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2016 to primary completion in Apr 2017, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2016
First posted
Jun 9, 2016
StartActual
Jun 2016
Primary completionActual
Apr 2017
CompletionActual
Apr 2017
Last update
Jul 6, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02794701
Responsible party
Ho Yu CHENG (post-doctoral fellow, Chinese University of Hong Kong) — Principal investigator
First posted
Jun 9, 2016
Start date
Jun 2016
Primary completion
Apr 2017
Completion
Apr 2017
Last update
Jul 6, 2018

Study contacts

Ho Yu CHENG, PhD, RN
principal investigator · The Nethersole School of Nursing, Chinese University of Hong Kong
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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