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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
Date last updated
21/10/2021

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
Recovery for intensive care survivors is limited by ongoing problems with walking, strength, fatigue, mental distress and cognitive morbidity known as 'Post Intensive Care Syndrome'. There has been increasing interest in ways that clinicians can support patients in their post ICU recovery.

The investigators are undertaking a co design approach to informing the design of a recovery pathway for patients who have been admitted to the intensive care to support them in their return to home, family and working responsibilities.
Trial website
https://clinicaltrials.gov/study/NCT05044221
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05044221