Measuring Outcomes of Activity in Intensive Care

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

312 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-27

Study Completion Date

2025-12-31

Brief Summary

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Millions of older adults are hospitalized for a critical illness each year and although they are more likely than ever to survive this illness, they commonly face significant morbidity in the form of disabilities in basic self-care activities and in mobility in the months and years afterwards. A better understanding of the underlying risk factors for disability following critical illness is greatly needed, including the effect that activity during hospitalization may have on these outcomes. Therefore, we designed the Measuring OutcomeS of Activity in Intensive Care (MOSAIC) observational study to evaluate the relationship between activity (measured more rigorously than in prior investigations) and disability, physical function, and cognitive function in survivors of critical illness 3 and 12 months after ICU discharge.

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Detailed Description

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The MOSAIC observational study will measure activity in critically ill patients for up to 28 days in the hospital using two different, objective measures, a clinical mobility scale and accelerometry. We will evaluate the independent association between activity and outcomes 3 and 12 months after ICU discharge. Specifically, Aim 1 will determine the relationship between activity and disability in ADLs and mobility. Aim 2a will determine the relationship between activity and physical and cognitive function. Aim 2b will evaluate physical and cognitive function as mediators of long-term disability. Aim 3a will determine the relationship between activity and biomarkers of inflammation and coagulation. Aim 3b will determine the relationship between these biomarkers of inflammation and coagulation and disability, physical and cognitive function.

Conditions

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Critical Illness Sepsis Mechanical Ventilation Physical Activity Disability Physical Muscle Weakness Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults (≥18 years old) with critical illness

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. adult patients (≥18 years old),
2. in a medical or surgical ICU at Vanderbilt University Medical Center or The Ohio State University Medical Center, and
3. are being treated for respiratory failure or shock.

3. Inability to live independently at baseline due to acquired or congenital disabling, physical, cognitive or mental health disorder requiring institutionalization (e.g., nursing home, skilled nursing facility, group home, long-term acute care hospital, rehab facility) or any patient who resides outside an institution with an inability to walk without the assistance of another person (e.g., patients with quadriplegia, paraplegia, double amputees, those with residual paralysis from stroke).
4. Acute or subacute severe neurologic (e.g., stroke anoxic injury, spinal cord injury) that is expected to prevent the patient from living independently after hospital discharge.
5. Body mass index \>50
6. Active substance abuse or psychotic disorder (e.g., schizophrenia or schizo-affective disorder), recent (within the past 6 months) serious suicidal gesture necessitating hospitalization
7. Blindness, deafness, or inability to understand English that will preclude follow-up evaluation. Patients with laryngectomies and those with hearing impairments are eligible for enrollment if their medical condition permits them to communicate with research staff.
8. Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely to withdraw life support measures within 24 hours of screening).
9. Prisoners
10. Patients who live further than 200 miles from an enrolling center and who do not regularly visit the area.
11. Patients who are homeless and have no secondary contact person available
12. Current enrollment in a study that does not allow co-enrollment

1. Attending physician refusal
2. Patient and/or surrogate refusal
3. 72-hour period of eligibility was exceeded before the patient was screened
14. Confirmed or suspected COVID-19 per local guidelines at the time of screen.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No