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Active, not recruitingNCT03115840MOSAICUpdated Feb 3, 2026

Measuring Outcomes of Activity in Intensive Care

An observational study in Critical Illness, Sepsis and Mechanical Ventilation, sponsored by Vanderbilt University Medical Center. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Vanderbilt University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
312
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Critical Illness
  • Sepsis
  • Mechanical Ventilation
  • Physical Activity
  • Disability Physical
  • Muscle Weakness
  • Cognitive Impairment
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's planned enrollment of 312 is above the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with medical or surgical critical illness

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.

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
312 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Adults (≥18 years old) with critical illness
06

What researchers measure

Primary outcomes

  1. Precipitating Events Project Disability Questionnaire

    Questionnaire assessment of activities of daily living and mobility

    Time frame: 12 months

  2. Life Space Assessment Questionnaire

    Questionnaire assessment of activities of community mobility

    Time frame: 12 months

Secondary outcomes

  1. Precipitating Events Project Disability Questionnaire

    Questionnaire assessment of activities of daily living and mobility

    Time frame: 3 months

  2. Life Space Assessment Questionnaire

    Questionnaire assessment of activities of community mobility

    Time frame: 3 months

  3. Survival

    Proportion of patients surviving at 30, 90, and 365 days

    Time frame: 30, 90, and 365 days

  4. Ventilator-free days

    Days alive and free of mechanical ventilation

    Time frame: out of 28 days

  5. Delirium and coma-free days

    Days alive and without delirium or coma

    Time frame: out of 28 days

  6. ICU Length of Stay

    Days spent in the ICU during the index hospitalization

    Time frame: up to 28 days

  7. Hospital Length of Stay

    Days spent in the hospital during the index hospitalization

    Time frame: up to 28 days

  8. Short Physical Performance Battery

    Performance Measure of Physical Function

    Time frame: 3 months

  9. Short Physical Performance Battery

    Performance Measure of Physical Function

    Time frame: 12 months

  10. Handgrip Dynamometry

    Performance Measure of Muscle Strength

    Time frame: 3 months

  11. Handgrip Dynamometry

    Performance Measure of Muscle Strength

    Time frame: 12 months

  12. Repeatable Battery for the Assessment of Neuropsychological Status

    Test of Global Cognition

    Time frame: 3 months

  13. Repeatable Battery for the Assessment of Neuropsychological Status

    Test of Global Cognition

    Time frame: 12 months

  14. Trail Making Test Parts A & B

    Test of Executive Function

    Time frame: 3 months

  15. Trail Making Test Parts A & B

    Test of Executive Function

    Time frame: 12 months

07

Study locations

2 sites
  • The Ohio State University Medical Center
    Columbus, Ohio 43210, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37212, United States
08

References and documents

Publications

  • Brummel NE, Balas MC, Morandi A, Ferrante LE, Gill TM, Ely EW. Understanding and reducing disability in older adults following critical illness. Crit Care Med. 2015 Jun;43(6):1265-75. doi: 10.1097/CCM.0000000000000924. PubMed 25756418 ↗
  • Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372. PubMed 24088092 ↗
  • Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802. PubMed 21470008 ↗
  • Gill TM, Allore HG, Gahbauer EA, Murphy TE. Change in disability after hospitalization or restricted activity in older persons. JAMA. 2010 Nov 3;304(17):1919-28. doi: 10.1001/jama.2010.1568. PubMed 21045098 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03115840
Lead sponsor
Vanderbilt University Medical Center
Collaborators
National Institute on Aging (NIA)
Responsible party
Wes Ely (Professor of Medicine, Allergy/Pulmonary & Critical Care, Vanderbilt University Medical Center) — Principal investigator
First posted
Apr 14, 2017
Start date
Mar 27, 2017
Primary completion
Feb 1, 2022
Completion
Dec 31, 2030 (estimated)
Last update
Feb 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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