SilicosisNCT02794701
Comprehensive Risk Assessment of People With Silicosis: A Population-based Study
An observational study of Silicosis, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Silicosis
- What is being tested?
- People with silicosis
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- With medically diagnosed mental illness, including major depression, or
- with active pulmonary tuberculosis
Trial locations and contacts
1 site in 1 country.
China1 site
The Nethersole School of Nursing, Chinese University of Hong Kong
Hong Kong SAR
About this study
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.
Read more
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
- Being tested
- People with silicosis
- Medical subject headings
- Silicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
People with silicosisOther
| Study group | Role | What they receive |
|---|---|---|
| people with silicosis | Not described Receives: Other: People with silicosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory symptoms and related physical limitation
examined by Hong Kong Chinese version of St. George's Respiratory Questionnaire
Measured: baseline
Psychological status
Anxiety and depression symptoms measured by the Chinese version of Hospital Anxiety and Depression Scale
Measured: baseline
Quality of life
examined by the SF-12v2
Measured: baseline
Social support
measured by the Chinese version of six-item Social Support Questionnaire
Measured: baseline
Body mass index
BMI in kg/m^2
Measured: baseline
waist circumference
WC in cm
Measured: baseline
12-hour fasting lipid profile
total-cholesterol, HDL-Cholesterol, LDL-cholesterol and triglycerides (in mmol/L)
Measured: baseline
12-hour fasting glucose
FG in mmol/L
Measured: baseline
fasting insulin level
insulin in pmol/L
Measured: baseline
12 hour fasting ascorbic acid level
vit-C in mg/dL
Measured: baseline
fasting high sensitivity C-reactive protein level
hs-CRP in mg/L
Measured: baseline
hemoglobin level
hemoglobin in g/dL
Measured: 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
Measured: baseline
Physical activity level
measured by the International Physical Activity Questionnaire - Short Form
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SilicosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Yu CHENG, Chinese University of Hong Kong
- Investigators
- Ho Yu CHENG, PhD, RN, Principal investigator, The Nethersole School of Nursing, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794701
- Sponsor's protocol ID
- CRE-2015.499
- Status last verified
- Jul 2018
- First submitted
- 30 May 2016
- Last updated
- 6 Jul 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Risk Assessment of People With Silicosis: A Population-based Study
- ClinicalTrials.gov ID
- NCT02794701
- Acronym / sponsor ID
- CRE-2015.499
- Conditions
- Silicosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| people with silicosis | – | Other: People with silicosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- With medically diagnosed mental illness, including major depression, or
- with active pulmonary tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| People with silicosis | Other | people with silicosis |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Silicosis
Not yet recruitingObservational study
Perioperative Risk Factors Related to the Prognosis of Lung Transplantation: A Retrospective Study
COPD, Interstitial Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho Yu CHENG, PhD, RN principal investigator
The Nethersole School of Nursing, Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Silicosis, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory symptoms and related physical limitation (time frame: baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.