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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05044221




Registration number
NCT05044221
Ethics application status
Date submitted
30/08/2021
Date registered
14/09/2021

Titles & IDs
Public title
Supporting the Recovery Needs of Patients Following Intensive Care
Scientific title
Supporting the Recovery Needs of Patients Following Intensive Care
Secondary ID [1] 0 0
RMH69389
Secondary ID [2] 0 0
2020.333
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Intensive Care Unit Syndrome 0 0
Post Intensive Care Syndrome 0 0
ICU Acquired Weakness 0 0
Intensive Care Unit Syndrome 0 0
Intensive Care Unit Acquired Weakness 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Former ICU patient and caregiver workshops
Other interventions - Health care professional workshops

Interviews: Past ICU patients and caregivers - Former ICU patients and their families that meet the following criteria: Adults \> 18 years and above who required at least 48 hours of invasive mechanical ventilation and were in the ICU at least 4 days with an ICU admission in the past five years; and able to participate in a workshop in English.

Interviews: Health care professionals - Active working health professionals with prior experience working directly in the ICU setting and/or care for ICU patients in their own clinical rea (acute, subacute and/or community settings).


Other interventions: Former ICU patient and caregiver workshops
In depth interviews and workshops will be conducted with individuals enrolled in the study.

Other interventions: Health care professional workshops
In depth interviews and workshops will be conducted with individuals enrolled in the study.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lived experiences and opinions
Timepoint [1] 0 0
3 months

Eligibility
Key inclusion criteria
* Hospitalized adults, aged 18 years or over
* Admitted to the ICU requiring invasive mechanical ventilation for > 48 hours and remain in the ICU for a minimum of four days
* Living at home before the current admission (not in a facility and/or no fixed abode)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Non-English speaking (insufficient English language skills to read and understand questionnaires and patient information consent form)
* Pre-existing documented cognitive impairment
* Spinal cord injury or other primary neuromuscular disease
* New lower limb fracture with altered weight bearing status
* Expected survival < 3 months according to the treating medical team
* Active substance abuse or psychosis
* Lack of access to telephone / computer or inability to use these resources independently (which would impact on ability to complete the intervention)
* Pregnancy
* Suicidality
* Incarcerated
* Cardiac surgery within this ICU admission (as these patients routinely receive a standard outpatient rehabilitation through cardiac rehabilitation)
* Poor premorbid mobility defined as < 10 metres ambulation +/- gait aid independently

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment postcode(s) [2] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05044221