TraumaNCT03219424
Predicting the Probability of Return To Work After Injury
An observational study of Trauma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
To evaluate return to work (RTW) status after moderate and major trauma in Hong Kong at one year after injury. To derive reliable prediction models for return to work. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- How many people
- 1,115 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2017to 28 Feb 2022
- 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: All adult patients aged 18 years or above who enter into the trauma registry of the hospitals involved in the study between 1 September 2017 and 31 August 2018 inclusive will be included.
Who may be able to join
- Aged 18 years or above
- Eligible for the trauma registry
- Working or seeking employment before injury
Who cannot join
- Isolated hip or pathological fractures
- Injury severity score (ISS) of 1
- Patients who are unwilling to enter the study
- Patients who have left Hong Kong
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting the Probability of Return to Work After Injury in Hong Kong: Prospective Multicentre Cohort Study
To evaluate return to work (RTW) status after moderate and major trauma in Hong Kong at one year after injury. To derive reliable prediction models for return to work.
Read the detailed description
Background:
Trauma is a leading cause not only of death worldwide but also of disability, and in Hong Kong it ranks sixth as a cause of death for all age groups. The implementation of trauma systems has improved the survival of injured patients in many settings including Hong Kong. However, the aim of trauma care for the injured person is not only to prolong life but also to restore patients to the best possible health status, and where applicable, to return to work. Survivors of trauma often experience late sequelae that have a major impact on almost all aspects of everyday life, and improvements in functional outcome and health status may continue for at least five years post-injury.
Objectives:
- to evaluate return to work (RTW) status after moderate and major trauma in Hong Kong at one year after injury;
- to derive reliable prediction models for RTW.
Study design:
This is a multi-centre, prospective long-term follow up cohort study of the 1163 trauma patients admitted to the Prince of Wales Hospital (PWH), Queen Elizabeth Hospital (QEH) and Tuen Mun Hospital (TMH) in Hong Kong in 2017-2018. Patients will be recruited within four weeks of ED attendance as soon as the patient is clinically stable and conscious. The follow-up period for return to work status of the 1163 trauma patients will extend from baseline to one year after trauma.
- Conditions
- Trauma
- Keywords
- Return to work status, Functional outcome, Quality of life
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work status at 12 months after injury
The proportion of trauma patients who return to work at 12 months after injury
Measured: 12 months after injury
Secondary outcomes (1)
Change of Glasgow Outcome Scale-Extended (GOSE) over time
Change of GOSE over time
Measured: On admission, 30 days after injury, 3 months after injury, 6 months after injury, 9 month after injury and 12 months after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2019
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong, Tuen Mun Hospital
- Responsible party
- Principal investigator, Colin Graham, Chinese University of Hong Kong
- Investigators
- Colin A Graham, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219424
- Sponsor's protocol ID
- CREC2016.667-T
- Status last verified
- Mar 2022
- First submitted
- 7 Jul 2017
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hung KKC, Leung LY, Yeung JHH, Wong TK, Yiu TY, Leung YK, Chan LPS, Wong JKS, Leung MPS, Goggins WB, Chan DYC, Lui CT, Ng WK, Ho HF, Cheng CH, Cheung NK, Graham CA. Return to work after injury in Hong Kong: prospective multi-center cohort study. Eur J Trauma Emerg Surg. 2022 Aug;48(4):3287-3298. doi: 10.1007/s00068-022-01899-x. Epub 2022 Feb 17.
PubMed 35175362
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Probability of Return to Work After Injury in Hong Kong: Prospective Multicentre Cohort Study
- ClinicalTrials.gov ID
- NCT03219424
- Acronym / sponsor ID
- CREC2016.667-T
- Conditions
- Trauma
- Keywords
- Return to work status, Functional outcome, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,115 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong, Tuen Mun Hospital
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 17 Jul 2017 (actual)
- 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.
To evaluate return to work (RTW) status after moderate and major trauma in Hong Kong at one year after injury. To derive reliable prediction models for return to work.
Detailed description
Background:
Trauma is a leading cause not only of death worldwide but also of disability, and in Hong Kong it ranks sixth as a cause of death for all age groups. The implementation of trauma systems has improved the survival of injured patients in many settings including Hong Kong. However, the aim of trauma care for the injured person is not only to prolong life but also to restore patients to the best possible health status, and where applicable, to return to work. Survivors of trauma often experience late sequelae that have a major impact on almost all aspects of everyday life, and improvements in functional outcome and health status may continue for at least five years post-injury.
Objectives:
- to evaluate return to work (RTW) status after moderate and major trauma in Hong Kong at one year after injury;
- to derive reliable prediction models for RTW.
Study design:
This is a multi-centre, prospective long-term follow up cohort study of the 1163 trauma patients admitted to the Prince of Wales Hospital (PWH), Queen Elizabeth Hospital (QEH) and Tuen Mun Hospital (TMH) in Hong Kong in 2017-2018. Patients will be recruited within four weeks of ED attendance as soon as the patient is clinically stable and conscious. The follow-up period for return to work status of the 1163 trauma patients will extend from baseline to one year after trauma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients aged 18 years or above who enter into the trauma registry of the hospitals involved in the study between 1 September 2017 and 31 August 2018 inclusive will be included.
Key inclusion criteria (3 listed)
- Aged 18 years or above
- Eligible for the trauma registry
- Working or seeking employment before injury
Key exclusion criteria (4 listed)
- Isolated hip or pathological fractures
- Injury severity score (ISS) of 1
- Patients who are unwilling to enter the study
- Patients who have left Hong Kong
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Return to work status at 12 months after injury
Time frame: 12 months after injury
The proportion of trauma patients who return to work at 12 months after injury
1 secondary outcome
Change of Glasgow Outcome Scale-Extended (GOSE) over time
Time frame: On admission, 30 days after injury, 3 months after injury, 6 months after injury, 9 month after injury and 12 months after injury
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 5 Apr 2022.
- Background: PubMed 35175362Hung KKC, Leung LY, Yeung JHH, Wong TK, Yiu TY, Leung YK, Chan LPS, Wong JKS, Leung MPS, Goggins WB, Chan DYC, Lui CT, Ng WK, Ho HF, Cheng CH, Cheung NK, Graham CA. Return to work after injury in Hong Kong: prospective multi-center cohort study. Eur J Trauma Emerg Surg. 2022 Aug;48(4):3287-3298. doi: 10.1007/s00068-022-01899-x. Epub 2022 Feb 17.
- Individual participant dataSharing planned: No
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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.
Colin A Graham, MD principal investigator
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 Trauma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 4 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 5 Apr 2022. 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 Hong Kong. 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?
Return to work status at 12 months after injury (time frame: 12 months after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03219424, which also lists 1 linked publication.
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 5 Apr 2022.