- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05044221
Supporting the Recovery Needs of Patients Following Intensive Care
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
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Victoria
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Melbourne, Victoria, Australia, 3050
- The Royal Melbourne Hospital
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Melbourne, Victoria, Australia, 3065
- St Vincent's Hospital Melbourne
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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In depth interviews and workshops will be conducted with individuals enrolled in the study.
Other Names:
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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).
|
In depth interviews and workshops will be conducted with individuals enrolled in the study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lived experiences and opinions
Time Frame: 3 months
|
Capability Opportunity Motivation Barriers and Theoretical Domains Framework will be used to interpret qualitative data from the workshops and interviews.
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3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020.333
- RMH69389 (OTHER: ERM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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