Measuring Outcomes of Activity in Intensive Care

Active, not recruiting

• Conditions: Mechanical Ventilation; Physical Activity; Disability Physical; Muscle Weakness; Critical Illness; Sepsis; Cognitive Impairment

• Registration Number: NCT03115840
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-03-27
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-14
• Primary Completion: 2022-02-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-23
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 312

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.

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Exclusion Criteria

1. Rapidly resolving organ failure criteria, indicated by planned immediate discontinuation of mechanical ventilation, NIPPV, and/or vasopressors at the time of screening for study enrollment, such that the patient will no longer meet inclusion criteria.

2. Cumulative hospital days (ICU plus non-ICU) of five or greater in the last 30 days prior to meeting all inclusion criteria.

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

13. Inability to obtain informed consent from the patient or an authorized representative within 72 hours of meeting all inclusion criteria for the following reasons:

    1. Attending physician refusal
    2. Patient and/or surrogate refusal
    3. 72-hour period of eligibility was exceeded before the patient was screened
    4. Patient unable to consent and no surrogate available within 72 hours of meeting all inclusion criteria

14. Confirmed or suspected COVID-19 per local guidelines at the time of screen.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Precipitating Events Project Disability Questionnaire	12 months	Questionnaire assessment of activities of daily living and mobility
Life Space Assessment Questionnaire	12 months	Questionnaire assessment of activities of community mobility

Secondary Outcome Measures

Name	Time	Method
Ventilator-free days	out of 28 days	Days alive and free of mechanical ventilation
Delirium and coma-free days	out of 28 days	Days alive and without delirium or coma
Hospital Length of Stay	up to 28 days	Days spent in the hospital during the index hospitalization
Short Physical Performance Battery	12 months	Performance Measure of Physical Function
Precipitating Events Project Disability Questionnaire	3 months	Questionnaire assessment of activities of daily living and mobility
Survival	30, 90, and 365 days	Proportion of patients surviving at 30, 90, and 365 days
Repeatable Battery for the Assessment of Neuropsychological Status	12 months	Test of Global Cognition
Life Space Assessment Questionnaire	3 months	Questionnaire assessment of activities of community mobility
ICU Length of Stay	up to 28 days	Days spent in the ICU during the index hospitalization
Handgrip Dynamometry	12 months	Performance Measure of Muscle Strength
Trail Making Test Parts A & B	12 months	Test of Executive Function

Trial Locations

Locations (2)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States