NCT02225938

Brief Summary

Increasingly patients with critical illness requiring life support in an intensive care unit are surviving their hospital admission. Currently the investigators do not know what effect the ICU admission, and the life support, has on their long-term quality of life and whether they can return to their pre-illness level of function following ICU. The investigators aim to test telephone follow-up of ICU survivors in assessing function and quality of life six months after ICU admission. Additionally, the investigators will identify if there are factors that lead to poor recovery. The investigators hope this can influence and change current ICU practice to improve recovery and long-term outcomes for patients. The investigators aim to select a total of 300 patients from ICU, 75 patients from each of the four ICUs. If they survive to hospital discharge, patients and their relatives will receive a telephone questionnaire at 6 months after the ICU admission that aims to assess their long-term outcomes, including physical, cognitive and emotional function, quality of life, and whether they have been able to return to work following ICU.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

5 active sites

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

Study Start

First participant enrolled

August 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 3, 2023

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

August 6, 2014

Last Update Submit

October 1, 2023

Conditions

Intensive Care Unit Syndrome

Keywords

Intensive CareRecoveryLong term outcomeFunction

Outcome Measures

Primary Outcomes (1)

  • Feasibility of telephone interview

    Determine feasibility of using a telephone interview to ascertain the functional recovery and quality of life and critically ill ICU survivors.

    At completion of telephone interview, expected average of 6 months

Secondary Outcomes (1)

  • Health related quality of life

    At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit

Other Outcomes (6)

  • Pre-ICU function

    At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit

  • Global function

    At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit

  • Physical activity

    At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit

  • +3 more other outcomes

Study Arms (1)

Intensive care survivors

Patients surviving an admission to an intensive care unit

Eligibility Criteria

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

300 critically ill patients who were mechanically ventilated \>24 hours in an intensive care unit who have survived to hospital discharge.

You may qualify if:

  • ICU patients who have been invasively mechanically ventilated for over 24 hours

You may not qualify if:

  • Patients aged less than 18 years old
  • A proven or suspected acute primary brain process that is likely to result in global impairment of conscious level or cognition (e.g. traumatic brain injury, subarachnoid haemorrhage, stroke or hypoxic brain injury after cardiac arrest)
  • Second or subsequent admission to ICU during a single hospital admission
  • Death is deemed imminent and inevitable
  • Participants who do not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

The Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Cabrini Hospital

Malvern, Victoria, 3144, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Epworth Hospital

Richmond, Victoria, 3121, Australia

Location

Related Publications (1)

  • Hodgson CL, Udy AA, Bailey M, Barrett J, Bellomo R, Bucknall T, Gabbe BJ, Higgins AM, Iwashyna TJ, Hunt-Smith J, Murray LJ, Myles PS, Ponsford J, Pilcher D, Walker C, Young M, Cooper DJ. The impact of disability in survivors of critical illness. Intensive Care Med. 2017 Jul;43(7):992-1001. doi: 10.1007/s00134-017-4830-0. Epub 2017 May 22.

    PMID: 28534110DERIVED

Study Officials

  • Carol Hodgson, PhD MRes

    ANZIC-RC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 26, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 3, 2023

Record last verified: 2018-08

Locations

AU(5)