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

Primary Purpose

Critical Illness, Delirium

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family involvement
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    All participants

    Arm Description

    Patients to receive mobility interventions from trained family members

    Outcomes

    Primary Outcome Measures

    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
    Feasibility - recruitment rate
    We define a successful recruitment rate as achieving enrolment of four patients per month over the duration of the trial
    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
    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.

    Secondary Outcome Measures

    Patient Delirium
    CAM-ICU
    Patient & Family PTSD symptoms
    IES-R
    Adverse Events
    Falls, hypotension, bradycardia, line removal, unplanned extubation, inappropriate family intervention, unexpected injuries
    Family satisfaction
    23-item Family Satisfaction in the ICU questionnaire; HADS scale

    Full Information

    First Posted
    September 19, 2023
    Last Updated
    October 4, 2023
    Sponsor
    St. Joseph's Healthcare Hamilton
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06071793
    Brief Title
    Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study
    Acronym
    FIT-ICU
    Official Title
    Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2024 (Anticipated)
    Study Completion Date
    July 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Joseph's Healthcare Hamilton

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical Illness, Delirium

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    All participants
    Arm Type
    Experimental
    Arm Description
    Patients to receive mobility interventions from trained family members
    Intervention Type
    Other
    Intervention Name(s)
    Family involvement
    Intervention Description
    Family delivery of mobility activities
    Primary Outcome Measure Information:
    Title
    Feasibility - consent rate
    Description
    We define a successful consent rate as > 70% of SDMs or patients approached to consent, agreeing to take part in the study
    Time Frame
    Study duration - up to one year
    Title
    Feasibility - recruitment rate
    Description
    We define a successful recruitment rate as achieving enrolment of four patients per month over the duration of the trial
    Time Frame
    Study duration - up to one year
    Title
    Feasibility - protocol adherence
    Description
    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
    Time Frame
    During ICU stay, censored at 1 month
    Title
    Feasibility - resources
    Description
    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.
    Time Frame
    Study duration - up to one year
    Secondary Outcome Measure Information:
    Title
    Patient Delirium
    Description
    CAM-ICU
    Time Frame
    During ICU stay, censored at 1 month
    Title
    Patient & Family PTSD symptoms
    Description
    IES-R
    Time Frame
    1 & 3 months
    Title
    Adverse Events
    Description
    Falls, hypotension, bradycardia, line removal, unplanned extubation, inappropriate family intervention, unexpected injuries
    Time Frame
    During ICU stay, censored at 1 month
    Title
    Family satisfaction
    Description
    23-item Family Satisfaction in the ICU questionnaire; HADS scale
    Time Frame
    1 & 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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