Early Mobilization of Older Adults in the Cardiovascular Intensive Care Unit
NCT ID: NCT03616873
Last Updated: 2020-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
147 participants
OBSERVATIONAL
2018-02-22
2020-04-30
Brief Summary
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The investigators will perform a prospective, pre/post-EM intervention study in adults aged ≥60 years old admitted to the Cardiovascular Intensive Care Unit (CICU) at the JGH. During a 3-month period, the investigators will prospectively enrol patients to the pre-intervention cohort. The EM intervention will then be implemented. During a 12-month period, the investigators will prospectively enrol patients to the intervention cohort. 1 and 12 months following hospital discharge, patients in the pre-intervention and post-intervention cohorts will be contacted by phone by a member of the research team to assess for functional status and quality of life measures.
The primary effectiveness outcome will be the mean improvement in level of function (LOF) during CICU admission and at 1 and 12 months. Covariates predicting improvement in LOF ("responsiveness") and ones which do not ("non-responsiveness") will be assessed. The recovery of physical function at 1 month and 6 months as measured by the SF-36 physical component summary score will be assessed. The SF-36 scores of the highest scoring tertile of LOF on hospital discharge will be compared with the lowest scoring tertile. Hospital readmission at 30 days and discharge home vs. healthcare facility will also be compared. For safety, the composite and individual components of the number of falls, injuries, and dislodgements over the total number of attempted mobility activities will be recorded. The results from the intervention cohort will be compared to the pre-intervention cohort for all results.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adults aged 60 or older
Early Mobilization
The EM program consists of a progression of functional activities from level of function (LOF) 0 (lowest mobility) to 5 (highest mobility). Each LOF has 3 primary activities designed to promote the patient to the next level. The nurse will begin with mobility activities based on the LOF that matches the patient's current status. The nurse and clinical partner will attempt and/or complete each LOF activity once per shift.
Interventions
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Early Mobilization
The EM program consists of a progression of functional activities from level of function (LOF) 0 (lowest mobility) to 5 (highest mobility). Each LOF has 3 primary activities designed to promote the patient to the next level. The nurse will begin with mobility activities based on the LOF that matches the patient's current status. The nurse and clinical partner will attempt and/or complete each LOF activity once per shift.
Eligibility Criteria
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Inclusion Criteria
* Age 60 years old or older
Exclusion Criteria
* Patients with prehospital LOF 0 (immobile), LOF 1 (bedbound) or 2 (can sit in chair only).
* Cardiac surgery patients will also be excluded.
60 Years
ALL
No
Sponsors
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Jewish General Hospital
OTHER
Lady Davis Institute
OTHER
Responsible Party
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Michael Goldfarb
Attending Staff, Division of Cardiology
Principal Investigators
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Michael Goldfarb, MD
Role: PRINCIPAL_INVESTIGATOR
Lady Davis Institute
Locations
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Jewish General Hospital / Lady Davis Institute
Montreal, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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17-188
Identifier Type: -
Identifier Source: org_study_id
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