Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study (NCT06071793) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study
Canada20 participantsStarted 2023-11-30
Plain-language summary
An ICU admission is stressful for not only patients but their families as well. Research has shown that involving family members during a loved one's ICU stay can be helpful for them, but there is not clear direction on the best way to do this. For patients, family presence as well as early movement during their ICU stay has been shown to help recovery from things like delirium (a state of confusion) faster, and might prevent the weakness that can happen with a stay in the ICU. In this study, the investigators will explore whether having family help with moving patients through physiotherapy guided exercise can help both patients and families have a better experience and result from their ICU stay.
The investigators hypothesize that family involvement in activities as part of an overall physiotherapy treatment plan will provide a tangible means for family members to engage in the care of their critically ill loved one, thus improving outcomes for both critically ill patients and family members.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults (≥18 years) in the ICU
* Anticipated length of stay ≥48 hours for whom a request for physiotherapy has been placed by the treating physician
* Appropriateness for physiotherapy confirmed by the unit's physiotherapist.
* Families will be eligible if they are able to be present in ICU during physiotherapist or research team work hours until they are cleared to deliver activities independently, then at least three times weekly thereafter.
Exclusion Criteria:
* Patients who are receiving end of life care
* Patients who have high risk injuries including spinal cord injury or spinal fractures, post-operative from spinal surgery, and untreated hip or long bone fractures
* Patients at risk of raised intracranial pressure (ICP) (e.g. Malignant middle cerebral artery stroke, large subarachnoid hemorrhage), admitted post trauma activation, post-operative from brain surgery or with external ventricular drain (EVD) in situ.
* Patients who are bed-bound or require mechanical lift at baseline who would not otherwise be offered physiotherapy services.
* Exclusion criteria for families include any major barriers to participation, i.e., physical, cognitive, emotional or capacity to understand and communicate with the team.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.