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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06071793
Other study ID # 15669
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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