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临床试验/NCT02794701
NCT02794701已完成不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
390
试验地点
1
主要终点
Body mass index

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Body mass index

时间窗: baseline

BMI in kg/m\^2

waist circumference

时间窗: baseline

WC in cm

Respiratory symptoms and related physical limitation

时间窗: baseline

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

Psychological status

时间窗: baseline

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

Quality of life

时间窗: baseline

examined by the SF-12v2

Social support

时间窗: baseline

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

12 hour fasting ascorbic acid level

时间窗: baseline

vit-C in mg/dL

fasting high sensitivity C-reactive protein level

时间窗: baseline

hs-CRP in mg/L

12-hour fasting lipid profile

时间窗: baseline

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

12-hour fasting glucose

时间窗: baseline

FG in mmol/L

fasting insulin level

时间窗: baseline

insulin in pmol/L

hemoglobin level

时间窗: baseline

hemoglobin in g/dL

smoking and drinking habits, vegetable and fruit intake

时间窗: baseline

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

Physical activity level

时间窗: baseline

measured by the International Physical Activity Questionnaire - Short Form

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ho Yu CHENG

post-doctoral fellow

Chinese University of Hong Kong

研究点 (1)

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