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

NCT02794701 | Completed

• 1 other identifier: CRE-2015.499
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Silicosis

Outcome Measures

Primary Outcomes (14)

• Respiratory symptoms and related physical limitation

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

  baseline

• Psychological status

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

  baseline

• Quality of life

  examined by the SF-12v2

  baseline

• Social support

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

  baseline

• Body mass index

  BMI in kg/m\^2

  baseline

• waist circumference

  WC in cm

  baseline

• 12-hour fasting lipid profile

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

  baseline

• 12-hour fasting glucose

  FG in mmol/L

  baseline

• fasting insulin level

  insulin in pmol/L

  baseline

• 12 hour fasting ascorbic acid level

  vit-C in mg/dL

  baseline

• fasting high sensitivity C-reactive protein level

  hs-CRP in mg/L

  baseline

• hemoglobin level

  hemoglobin in g/dL

  baseline

• smoking and drinking habits, vegetable and fruit intake

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

  baseline

• Physical activity level

  measured by the International Physical Activity Questionnaire - Short Form

  baseline

Study Arms (1)

people with silicosis

Other: People with silicosis

Interventions

People with silicosis OTHER

people with silicosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Nethersole School of Nursing, Chinese University of Hong Kong

Hong Kong SAR, China

Location

MeSH Terms

Conditions

Silicosis

Condition Hierarchy (Ancestors)

Pneumoconiosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Occupational Diseases

Study Officials

• Ho Yu CHENG, PhD, RN

  The Nethersole School of Nursing, Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post-doctoral fellow

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 9, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)