New treatment option for Critical Illness
Official title Pilot Feasibility Study of a Pragmatic Mixed-Methods Randomized Controlled Trial on a Follow-Up Bundle of Care for ICU Survivors and Caregivers
ClinicalTrials.gov ID: NCT06681649
What this study is testing
- What it's testing
- \~80% of ICU survivors experience profound long-term cognitive, physical, and psychiatric impairments known as post-intensive care syndrome (PICS). Caregivers additionally experience similar detrimental psychosocial effects following discharge.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- ICU survivors
- Adult patients (age greater than or equal to 18 years)
- Life expectancy greater than or equal to 6 months as determined by the attending physician
- High risk for long-term functional sequelae following ICU discharge, defined as ICU stay greater than or equal to 4 days, or involving at least one...
- mechanical ventilation (any, i.e., invasive or non-invasive)
You likely can't join if
- ICU survivors and caregivers
- Neurological or communication difficulties which would preclude completion of follow-up assessments or participation in focus groups
- Inability to speak or read English (required for completion of standardized questionnaires, clinical assessments, and for participation in focus...
- Failure to provide consent/failure to have consent provided by a substitute decision maker
See the full eligibility criteria
- ICU survivors
- Adult patients (age greater than or equal to 18 years)
- Life expectancy greater than or equal to 6 months as determined by the attending physician
- High risk for long-term functional sequelae following ICU discharge, defined as ICU stay greater than or equal to 4 days, or involving at least one of:
- mechanical ventilation (any, i.e., invasive or non-invasive)
- tracheostomy
- delirium (defined as Confusion Assessment Method (CAM) positive or documented history of delirium in the patient's medical record by the clinical care team at some point during their ICU admission)
- lack of access to a primary care physician for clinical follow-up
- access to email or mail to complete follow-up questionnaires
- presence of an informal caregiver
- Caregivers
- Informal caregiver (e.g., spouse, offspring) for ICU survivor as defined above
- Adult (age greater than or equal to 18 years)
- ICU survivors and caregivers
- Neurological or communication difficulties which would preclude completion of follow-up assessments or participation in focus groups
- Inability to speak or read English (required for completion of standardized questionnaires, clinical assessments, and for participation in focus groups)
- Failure to provide consent/failure to have consent provided by a substitute decision maker
The study team makes the final eligibility decision.
Where it's taking place
- Kingston, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kingston, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.