NCT02917694

Brief Summary

This study aims to assess the feasibility of obtaining details about a patients previous level of function from the patient of friend/relative, after they have been admitted an intensive care unit (ICU). It will also assess the feasibility of re-assessing level of function at 6 months after the patient has been discharged from ICU.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

September 26, 2016

Last Update Submit

May 18, 2018

Conditions

Multiple Trauma

Outcome Measures

Primary Outcomes (1)

  • WHODAS 2.0 completion rate

    Number of questionnaires completed/returned on admission to ICU

    2 days

Secondary Outcomes (2)

  • Time to questionnaire completion rate

    2 days

  • WHODAS 2.0 completion rate

    6 months post ICU discharge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to ICU after multiple trauma

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study
  • Participants relative or friend (consultee) is willing and able to give informed consent for participation in the study (where the patient is unable to give informed consent)
  • Male or Female, aged 18 years or above
  • Injury Severity Score greater than 9
  • Admitted as an emergency to AICU
  • Experienced at least 24 hours level three care during their admission

You may not qualify if:

  • Non UK resident (due to potential loss to follow up)
  • Unwilling to consent
  • No GP details available
  • Patients with a palliative diagnosis or established on a palliative treatment pathway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Rebekah Haylett, BSc (Hons)

    Oxfod University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 28, 2016

Study Start

November 1, 2016

Primary Completion

May 5, 2018

Study Completion

May 5, 2018

Last Updated

May 21, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)