Critical IllnessFIT-ICUNCT06071793
Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study
A study testing Family involvement in people with Critical Illness and Delirium, run by St. Joseph's Healthcare Hamilton at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Delirium
- What is being tested?
- Family involvement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesCanada
- Study dates
- 30 Nov 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Brant Community Healthcare System
Brantford, Ontario, N3R 1G9
St Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
About this study
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.
- Conditions
- Critical Illness, Delirium
- Being tested
- Family involvement
- Medical subject headings
- Critical Illness, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family involvementOther
Family delivery of mobility activities
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Patients to receive mobility interventions from trained family members Receives: Other: Family involvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - consent rate
We define a successful consent rate as > 70% of SDMs or patients approached to consent, agreeing to take part in the study
Measured: Study duration - up to one year
Feasibility - recruitment rate
We define a successful recruitment rate as achieving enrolment of four patients per month over the duration of the trial
Measured: Study duration - up to one year
Feasibility - protocol adherence
We define successful adherence as average family involvement in ≥ 3 sessions/week. Furthermore, adherence to documentation of involvement will be successful if documented by family for ≥80% of sessions
Measured: During ICU stay, censored at 1 month
Feasibility - resources
Physiotherapist and nurse outcomes will include inability to train families due to physiotherapy or team resources, and number of sessions per week cancelled due to inadequate staffing resources during the patients ICU stay.
Measured: Study duration - up to one year
Secondary outcomes (4)
Patient Delirium
CAM-ICU
Measured: During ICU stay, censored at 1 month
Patient & Family PTSD symptoms
IES-R
Measured: 1 & 3 months
Adverse Events
Falls, hypotension, bradycardia, line removal, unplanned extubation, inappropriate family intervention, unexpected injuries
Measured: During ICU stay, censored at 1 month
Family satisfaction
23-item Family Satisfaction in the ICU questionnaire; HADS scale
Measured: 1 & 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start30 Nov 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberley Lewis, St. Joseph's Healthcare Hamilton
- Investigators
- Kimberley Lewis, MD, Principal investigator, The Research Institute of St Joe's HamiltonLaiya Carayannopoulos, MD, Principal investigator, The Research Institute of St Joe's Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071793
- Sponsor's protocol ID
- 15669
- Acronym
- FIT-ICU
- Status last verified
- Jul 2025
- First submitted
- 19 Sep 2023
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study
- ClinicalTrials.gov ID
- NCT06071793
- Acronym / sponsor ID
- FIT-ICU / 15669
- Conditions
- Critical Illness, Delirium
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Other: Family involvementPatients to receive mobility interventions from trained family members |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family involvementFamily delivery of mobility activities | Other | All participants |
Primary outcome
Feasibility - consent rate
Time frame: Study duration - up to one year
We define a successful consent rate as > 70% of SDMs or patients approached to consent, agreeing to take part in the study
Feasibility - recruitment rate
Time frame: Study duration - up to one year
We define a successful recruitment rate as achieving enrolment of four patients per month over the duration of the trial
Feasibility - protocol adherence
Time frame: During ICU stay, censored at 1 month
We define successful adherence as average family involvement in ≥ 3 sessions/week. Furthermore, adherence to documentation of involvement will be successful if documented by family for ≥80% of sessions
Feasibility - resources
Time frame: Study duration - up to one year
Physiotherapist and nurse outcomes will include inability to train families due to physiotherapy or team resources, and number of sessions per week cancelled due to inadequate staffing resources during the patients ICU stay.
4 secondary outcomes
Patient Delirium
Time frame: During ICU stay, censored at 1 month
Patient & Family PTSD symptoms
Time frame: 1 & 3 months
Adverse Events
Time frame: During ICU stay, censored at 1 month
Family satisfaction
Time frame: 1 & 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberley Lewis, MD principal investigator
The Research Institute of St Joe's Hamilton
Laiya Carayannopoulos, MD principal investigator
The Research Institute of St Joe's Hamilton
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family involvement in people with Critical Illness and Delirium, run by St. Joseph's Healthcare Hamilton at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - consent rate (time frame: Study duration - up to one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.