Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study

Critical Illness Clinical Trial

— FIT-ICU  

Official title:

Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06071793
• Other study ID #: 15669
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: March 21, 2025

Study information

• Verified date: June 2024
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 21, 2025
• Est. primary completion date: March 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Delirium

Intervention

Other:
• Family involvement
Family delivery of mobility activities

Locations

Country	Name	City	State
Canada	St Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Study duration - up to one year
Primary	Feasibility - recruitment rate	We define a successful recruitment rate as achieving enrolment of four patients per month over the duration of the trial	Study duration - up to one year
Primary	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	During ICU stay, censored at 1 month
Primary	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.	Study duration - up to one year
Secondary	Patient Delirium	CAM-ICU	During ICU stay, censored at 1 month
Secondary	Patient & Family PTSD symptoms	IES-R	1 & 3 months
Secondary	Adverse Events	Falls, hypotension, bradycardia, line removal, unplanned extubation, inappropriate family intervention, unexpected injuries	During ICU stay, censored at 1 month
Secondary	Family satisfaction	23-item Family Satisfaction in the ICU questionnaire; HADS scale	1 & 3 months