Clinical trial NCT02794701: Comprehensive Risk Assessment of People With Silicosis: A Population-based Study
Official title: Comprehensive Risk Assessment of People With Silicosis: A Population-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Silicosis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


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

Primary outcomes:
measure: Respiratory symptoms and related physical limitation
timeFrame: baseline
measure: Psychological status
timeFrame: baseline
measure: Quality of life
timeFrame: baseline
measure: Social support
timeFrame: baseline
measure: Body mass index
timeFrame: baseline
measure: waist circumference
timeFrame: baseline
measure: 12-hour fasting lipid profile
timeFrame: baseline
measure: 12-hour fasting glucose
timeFrame: baseline
measure: fasting insulin level
timeFrame: baseline
measure: 12 hour fasting ascorbic acid level
timeFrame: baseline
measure: fasting high sensitivity C-reactive protein level
timeFrame: baseline
measure: hemoglobin level
timeFrame: baseline
measure: smoking and drinking habits, vegetable and fruit intake
timeFrame: baseline
measure: Physical activity level
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: The Nethersole School of Nursing, Chinese University of Hong Kong
Study officials:
affiliation: The Nethersole School of Nursing, Chinese University of Hong Kong
name: Ho Yu CHENG, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: