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

NCT06071793 | Active Not Recruiting

• 1 other identifier: 15669
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Critical Illness; Delirium

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Patient Delirium

  During ICU stay, censored at 1 month

• Patient & Family PTSD symptoms

  1 & 3 months

• Adverse Events

  During ICU stay, censored at 1 month

• Family satisfaction

  1 & 3 months

Study Arms (1)

All participants

EXPERIMENTAL

Patients to receive mobility interventions from trained family members

Other: Family involvement

Interventions

Family involvement OTHER

Family delivery of mobility activities

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (3)

Brant Community Healthcare System

Brantford, Ontario, N3R 1G9, Canada

Location

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

MeSH Terms

Conditions

Critical Illness; Delirium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kimberley Lewis, MD

  The Research Institute of St Joe's Hamilton

  PRINCIPAL INVESTIGATOR

• Laiya Carayannopoulos, MD

  The Research Institute of St Joe's Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Intensivist

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 6, 2023
• Study Start: November 30, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)