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TraumaβioςNCT02508675

Non-fatal Outcome After Trauma

An observational study of Trauma, run by Network Emergency Care Brabant.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The major aim of this project is to investigate the prevalence, recovery patterns and risk factors for health related quality of life functional, psychological, societal and economic outcome after trauma. Another aim is to validate the WHO Quality Of Life-bref (WHOQOL-Bref) questionnaire for the trauma population. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Trauma
How many people
6,500 participants
Where
No sites listed yet
Study dates
Aug 2015to Jul 2018
How long will I take part?
2 Years
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: patients seen at the Emergency Department (ED) which are admitted to the Intensive Care Unit (ICU) or ward after getting injured, with a minimal age of 18 years old.

Who may be able to join

  • patients seen at the ED which are admitted to the ICU or ward after getting injured
  • all types and severities of injury (Injury Severity Score (ISS) 1-75)
  • a minimal age of 18 years old
  • sufficient knowledge of the Dutch language

Who cannot join

  • patients who are dead on arrival or decease in the ED
  • pathological fracture (i.e., the bones are weakened by disease, for example by a tumor)
  • patients who die in the hospital will drop out the study and will not be included in the analyses

About this study

Official title: Prevalence, Recovery Patterns and Risk Factors of Non-fatal Outcome and Costs After Trauma; a Prospective Follow up Study

The major aim of this project is to investigate the prevalence, recovery patterns and risk factors for health related quality of life functional, psychological, societal and economic outcome after trauma. Another aim is to validate the WHO Quality Of Life-bref (WHOQOL-Bref) questionnaire for the trauma population.

Read the detailed description

Patients aged 18 years and older admitted in a hospital in Brabant after a trauma, independent of severity or type of injury are included in the study. Patients who decease during hospital stay or transferred to another hospital outside the borders of trauma region Brabant will be excluded. Socio-demographic characteristics, functional and psychological outcome and Health Related Quality of Life (HRQoL) shortly after trauma will be measured. Subsequently the same items will be measured after 1, 3, 6, 12 and 24 months. Outcomes will be assessed using questionnaires. The primary outcome parameters are: short and long term HRQoL, functional and psychological outcome, and Healthcare and societal costs in injured patients. Secondary outcome measures are Return to Work and health care consumption.

Conditions
Trauma
Keywords
injury, risk factors, outcome, costs
Medical subject headings
Wounds and Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short and longterm HRQoL

    self-reported questionnaire

    Measured: 2 years

  2. Functional outcome

    self-reported questionnaire

    Measured: 2 years

  3. Healthcare and societal costs

    self-reported questionnaire and information from registries

    Measured: 2 years

  4. Psychological outcome

    self-reported questionnaire

    Measured: 2 years

  5. Social outcome

    self-reported questionnaire

    Measured: 2 years

Secondary outcomes (2)

  1. Return to work (RtW)

    self-reported questionnaire

    Measured: 2 years

  2. Health care consumption

    self-reported questionnaire and information from registries

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJul 2018 (estimated)
  4. Study completionJul 2018 (estimated)

Resources

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
6,500 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02508675
Sponsor's protocol ID
NL50258.028.14
Acronym
βioς
Status last verified
Mar 2018
First submitted
23 Jul 2015
Last updated
29 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • de Munter L, van de Ree CLP, van der Jagt OP, Gosens T, Maas HAAM, de Jongh MAC. Trajectories and prognostic factors for recovery after hip fracture: a longitudinal cohort study. Int Orthop. 2022 Dec;46(12):2913-2926. doi: 10.1007/s00264-022-05561-4. Epub 2022 Sep 6.

    PubMed 36066616

  • de Munter L, Polinder S, Havermans RJM, Steyerberg EW, de Jongh MAC. Prognostic factors for recovery of health status after injury: a prospective multicentre cohort study. BMJ Open. 2021 Jan 6;11(1):e038707. doi: 10.1136/bmjopen-2020-038707.

    PubMed 33408198

  • Brouwers L, de Jongh MAC, de Munter L, Edwards M, Lansink KWW. Prognostic factors and quality of life after pelvic fractures. The Brabant Injury Outcome Surveillance (BIOS) study. PLoS One. 2020 Jun 11;15(6):e0233690. doi: 10.1371/journal.pone.0233690. eCollection 2020.

    PubMed 32525901

  • Kruithof N, Polinder S, de Munter L, van de Ree CLP, Lansink KWW, de Jongh MAC; BIOS-group. Health status and psychological outcomes after trauma: A prospective multicenter cohort study. PLoS One. 2020 Apr 21;15(4):e0231649. doi: 10.1371/journal.pone.0231649. eCollection 2020.

    PubMed 32315373

  • de Munter L, Polinder S, Haagsma JA, Kruithof N, van de Ree CLP, Steyerberg EW, de Jongh M. Prevalence and Prognostic Factors for Psychological Distress After Trauma. Arch Phys Med Rehabil. 2020 May;101(5):877-884. doi: 10.1016/j.apmr.2019.10.196. Epub 2019 Dec 23.

    PubMed 31874154

  • van de Ree CLP, Landers MJF, Kruithof N, de Munter L, Slaets JPJ, Gosens T, de Jongh MAC. Effect of frailty on quality of life in elderly patients after hip fracture: a longitudinal study. BMJ Open. 2019 Jul 18;9(7):e025941. doi: 10.1136/bmjopen-2018-025941.

    PubMed 31324679

  • Kruithof N, Haagsma JA, Karabatzakis M, Cnossen MC, de Munter L, van de Ree CLP, de Jongh MAC, Polinder S. Validation and reliability of the Abbreviated World Health Organization Quality of Life Instrument (WHOQOL-BREF) in the hospitalized trauma population. Injury. 2018 Oct;49(10):1796-1804. doi: 10.1016/j.injury.2018.08.016. Epub 2018 Aug 23.

    PubMed 30154022

  • de Jongh MA, Kruithof N, Gosens T, van de Ree CL, de Munter L, Brouwers L, Polinder S, Lansink KW; BIOS-group. Prevalence, recovery patterns and predictors of quality of life and costs after non-fatal injury: the Brabant Injury Outcome Surveillance (BIOS) study. Inj Prev. 2017 Feb;23(1):59. doi: 10.1136/injuryprev-2016-042032. Epub 2016 May 6.

    PubMed 27154507

Questions about this trial

What is this clinical trial studying?

An observational study of Trauma, run by Network Emergency Care Brabant.

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 3 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: status not confirmed, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Short and longterm HRQoL (time frame: 2 years). The study lists 5 primary outcomes in all. 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 NCT02508675, which also lists 8 linked publications.

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 29 Mar 2018.

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