Comprehensive Risk Assessment of People With Silicosis: A Population-based Study
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|ClinicalTrials.gov Identifier: NCT02794701|
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : July 6, 2018
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|
|Study Type :||Observational|
|Actual Enrollment :||390 participants|
|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|
|people with silicosis||
Other: People with silicosis
- 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
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
|The Nethersole School of Nursing, Chinese University of Hong Kong|
|Hong Kong SAR, China|
|Principal Investigator:||Ho Yu CHENG, PhD, RN||The Nethersole School of Nursing, Chinese University of Hong Kong|