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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

Tracking Information
First Submitted Date May 30, 2016
First Posted Date June 9, 2016
Last Update Posted Date July 6, 2018
Actual Study Start Date June 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2016)
  • 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 ]
    vit-C in mg/dL
  • fasting high sensitivity C-reactive protein level [ Time Frame: baseline ]
    hs-CRP in mg/L
  • hemoglobin level [ Time Frame: baseline ]
    hemoglobin in g/dL
  • 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
  • Physical activity level [ Time Frame: baseline ]
    measured by the International Physical Activity Questionnaire - Short Form
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comprehensive Risk Assessment of People With Silicosis: A Population-based Study
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 Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Silicosis
Intervention Other: People with silicosis
Study Groups/Cohorts people with silicosis
Intervention: Other: People with silicosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 5, 2018)
390
Original Estimated Enrollment
 (submitted: June 5, 2016)
320
Actual Study Completion Date April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02794701
Other Study ID Numbers CRE-2015.499
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ho Yu CHENG, Chinese University of Hong Kong
Study Sponsor Chinese University of Hong Kong
Collaborators Not Provided
Investigators
Principal Investigator: Ho Yu CHENG, PhD, RN The Nethersole School of Nursing, Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date July 2018