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Behavioural Intervention

Family Integration in Therapy for Critical Illness (FIT-ICU Trial)

N/A

Recruiting

Research Sponsored by St. Joseph's Healthcare Hamilton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (≥18 years) in the ICU

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study duration - up to one year

Awards & highlights

FIT-ICU Trial Summary

This trial will explore if involving family in ICU care helps patients and their families with their experience and recovery.

Who is the study for?

This trial is for adults over 18 in the ICU, expected to stay at least 48 hours and have been recommended for physiotherapy. Family members who can be present during therapy sessions are also included. It's not for patients receiving end-of-life care, with certain high-risk injuries or conditions like severe brain injury, or those bed-bound before ICU admission.Check my eligibility

What is being tested?

The study tests if involving family in physiotherapy activities helps improve outcomes for both ICU patients and their families. The idea is that family participation might speed up recovery from delirium and prevent weakness associated with long ICU stays.See study design

What are the potential side effects?

Since this intervention involves non-medical treatment (family involvement), there aren't typical drug side effects. However, potential risks may include physical strain on family members or emotional stress related to participating in the care of a critically ill relative.

FIT-ICU Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult (18 or older) currently in the ICU.

FIT-ICU Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study duration - up to one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study duration - up to one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and study duration - up to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility - consent rate

Feasibility - protocol adherence

Feasibility - recruitment rate

+1 more

Secondary outcome measures

Adverse Events

Family satisfaction

Patient & Family PTSD symptoms

+1 more

FIT-ICU Trial Design

1Treatment groups

Experimental Treatment

Group I: All participantsExperimental Treatment1 Intervention

Patients to receive mobility interventions from trained family members

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Joseph's Healthcare HamiltonLead Sponsor

196 Previous Clinical Trials

25,524 Total Patients Enrolled

2 Trials studying Critical Illness

1,126 Patients Enrolled for Critical Illness

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study currently seeking participants?

"The information on clinicaltrials.gov indicates that this specific trial is no longer enlisting patients as it was first posted on November 30th, 2023 and last updated on November 3rd, 2023. However, there are 278 other medical studies actively looking for participants currently."

Answered by AI

What goal is this clinical research endeavor striving to realize?

"The trial's principal aim is to measure the feasibility of consenting participants, and it will be evaluated over a period spanning up to 12 months. Secondary objectives include: assessing PTSD symptoms (IES-R), monitoring for Adverse Events such as hypotension, bradycardia etc., and gauging Family Satisfaction in the ICU with a 23 item questionnaire & HADS scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kimberley Lewis 2023. "Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06071793.