Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609001037291
Ethics application status
Approved
Date submitted
11/11/2009
Date registered
4/12/2009
Date last updated
21/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Health-related quality of life in survivors of H1N1 (swine) influenza admitted to intensive care
Scientific title
Patients admitted to the Intensive Care Unit (ICU) with H1N1 influenza undergoing standard care including ICU and mechanical ventilation compared to the normal age and sex matched population and evaluating the effects on health-related quality of life.
Secondary ID [1] 263087 0
Quality of life in H1N1 survivors admitted to ICU
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with H1N1 influenza and admission to ICU and undergoing mechanical ventilation 252179 0
Condition category
Condition code
Physical Medicine / Rehabilitation 252376 252376 0 0
Physiotherapy
Infection 252524 252524 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The patients included in this trial have been exposed to H1N1 infection, admitted to an ICU and undergone a period of mechanical ventilation.

The health-related quality of life will be observed in these patients over a period of twelve months following ICU discharge (at six and twelve month time points).

Patients will undergo standard hospital and allied health care during and after their ICU admission, and this is usually delivered in a problem-based manner, this may not be standardized.
Intervention code [1] 241539 0
Not applicable
Comparator / control treatment
Normative healthy age and sex matched population (1995 National Health Survey: SF-36 population norms, Australia. Canberra: Australian Bureau of Statistics; 1997).

The cohort will also be compared with other national and international HR-QoL following ICU data.

Dowdy DW, Eid MP, Sedrakyan A, et al. Quality of life in adult survivors of critical illness: a systematic review of the literature. Intensive Care Med. May 2005;31(5):611-620.

Boyle M, Murgo M, Adamson H, Gill J, Elliott D, Crawford M. The effect of chronic pain on health related quality of life amongst intensive care survivors. Aust Crit Care. Aug 2004;17(3):104-106, 108-113.

Elliott D, Mudaliar Y, Kim C. Examining discharge outcomes and health status of critically ill patients: some practical considerations. Intensive Crit Care Nurs. Dec 2004;20(6):366-377.
Control group
Historical

Outcomes
Primary outcome [1] 253251 0
Health-related quality of life, measured by two HR-QoL questionnaires (the SF-36 Version 2 (Australian version) and the Assessment of Quality of Life (AQoL).
Timepoint [1] 253251 0
6 and 12 months following discharge from the intensive care unit
Secondary outcome [1] 262219 0
Return to work, assessed by telephone interview.
Timepoint [1] 262219 0
6 and 12 months following discharge from the intensive care unit

Eligibility
Key inclusion criteria
H1N1 confirmed infection
Age > 18
Admitted to ICU
Undergoing intubation and mechanical ventilaton
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speaking

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244008 0
Self funded/Unfunded
Name [1] 244008 0
N/A
Country [1] 244008 0
Primary sponsor type
Hospital
Name
Austin Health
Address
Studley Road
Heidelberg
Victoria, 3084
Country
Australia
Secondary sponsor category [1] 251359 0
Hospital
Name [1] 251359 0
Royal Melbourne Hospital
Address [1] 251359 0
Grattan Street Parkville Victoria, 3050
Country [1] 251359 0
Australia
Other collaborator category [1] 954 0
Other
Name [1] 954 0
Australian and New Zealand Intensive Care Society (ANZICS) Influenza Investigators
Address [1] 954 0
C/O Intensive Care Department Austin Health Studley Road Heidelberg Victoria, 3084
Country [1] 954 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244112 0
Austin Health
Ethics committee address [1] 244112 0
Ethics committee country [1] 244112 0
Australia
Date submitted for ethics approval [1] 244112 0
Approval date [1] 244112 0
Ethics approval number [1] 244112 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30498 0
Address 30498 0
Country 30498 0
Phone 30498 0
Fax 30498 0
Email 30498 0
Contact person for public queries
Name 13745 0
Elizabeth Skinner
Address 13745 0
Senior Clinician Physiotherapist Intensive Care Royal Melbourne Hospital Grattan Street Parkville, 3050 Victoria
Country 13745 0
Australia
Phone 13745 0
+61 (0)419101708
Fax 13745 0
Email 13745 0
[email protected]
Contact person for scientific queries
Name 4673 0
Elizabeth Skinner
Address 4673 0
Senior Clinician Physiotherapist, Intensive Care Monash Medical Centre 246 Clayton Road Clayton 3168 Victoria
Country 4673 0
Australia
Phone 4673 0
+61 (0)419101708
Fax 4673 0
Email 4673 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHealth-related quality of life in australasian survivors of H1N1 influenza undergoing mechanical ventilation a multicenter cohort study.2015https://dx.doi.org/10.1513/AnnalsATS.201412-568OC
N.B. These documents automatically identified may not have been verified by the study sponsor.