Clinical Trials Directory

Trials / Completed

CompletedNCT03616873

Early Mobilization of Older Adults in the Cardiovascular Intensive Care Unit

Status
Completed
Phase
Study type
Observational
Enrollment
147 (actual)
Sponsor
Lady Davis Institute · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

Summary

An early mobilization (EM) program will be implemented in the Cardiovascular Intensive Care Unit at the Jewish General Hospital (JGH), an academic tertiary hospital in Montreal, Quebec. 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.

Conditions

Interventions

TypeNameDescription
OTHEREarly MobilizationThe 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.

Timeline

Start date
2018-02-22
Primary completion
2020-04-30
Completion
2020-04-30
First posted
2018-08-06
Last updated
2020-10-14

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03616873. Inclusion in this directory is not an endorsement.