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Critical IllnessMOSAICNCT03115840

Measuring Outcomes of Activity in Intensive Care

An observational study of Critical Illness and Sepsis, run by Vanderbilt University Medical Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Illness, Sepsis, Mechanical Ventilation
How many people
312 participants
Where
2 sitesUnited States
Study dates
27 Mar 2017to 31 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with medical or surgical critical illness

Who may be able to join

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

Who cannot join

  • 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.
  • Cumulative hospital days (ICU plus non-ICU) of five or greater in the last 30 days prior to meeting all inclusion criteria.
  • 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).
  • 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.
  • Body mass index >50
  • Active substance abuse or psychotic disorder (e.g., schizophrenia or schizo-affective disorder), recent (within the past 6 months) serious suicidal gesture necessitating hospitalization
Show all 18Show fewer
  • 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.
  • 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).
  • Prisoners
  • Patients who live further than 200 miles from an enrolling center and who do not regularly visit the area.
  • Patients who are homeless and have no secondary contact person available
  • Current enrollment in a study that does not allow co-enrollment
  • Inability to obtain informed consent from the patient or an authorized representative within 72 hours of meeting all inclusion criteria for the following reasons:
  • Attending physician refusal
  • Patient and/or surrogate refusal
  • 72-hour period of eligibility was exceeded before the patient was screened
  • Patient unable to consent and no surrogate available within 72 hours of meeting all inclusion criteria
  • Confirmed or suspected COVID-19 per local guidelines at the time of screen.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

Other trials in United States

About this study

Official title: Long-term Outcomes of Physical Activity in Older Adults With Critical Illness

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.

Medical subject headings
Critical Illness, Sepsis, Motor Activity, Muscle Weakness, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03115840
Study groupRoleWhat they receive
Adults (≥18 years old) with critical illnessNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Precipitating Events Project Disability Questionnaire

    Questionnaire assessment of activities of daily living and mobility

    Measured: 12 months

  2. Life Space Assessment Questionnaire

    Questionnaire assessment of activities of community mobility

    Measured: 12 months

Secondary outcomes (15)

  1. Precipitating Events Project Disability Questionnaire

    Questionnaire assessment of activities of daily living and mobility

    Measured: 3 months

  2. Life Space Assessment Questionnaire

    Questionnaire assessment of activities of community mobility

    Measured: 3 months

  3. Survival

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

    Measured: 30, 90, and 365 days

  4. Ventilator-free days

    Days alive and free of mechanical ventilation

    Measured: out of 28 days

  5. Delirium and coma-free days

    Days alive and without delirium or coma

    Measured: out of 28 days

  6. ICU Length of Stay

    Days spent in the ICU during the index hospitalization

    Measured: up to 28 days

  7. Hospital Length of Stay

    Days spent in the hospital during the index hospitalization

    Measured: up to 28 days

  8. Short Physical Performance Battery

    Performance Measure of Physical Function

    Measured: 3 months

  9. Short Physical Performance Battery

    Performance Measure of Physical Function

    Measured: 12 months

  10. Handgrip Dynamometry

    Performance Measure of Muscle Strength

    Measured: 3 months

  11. Handgrip Dynamometry

    Performance Measure of Muscle Strength

    Measured: 12 months

  12. Repeatable Battery for the Assessment of Neuropsychological Status

    Test of Global Cognition

    Measured: 3 months

  13. Repeatable Battery for the Assessment of Neuropsychological Status

    Test of Global Cognition

    Measured: 12 months

  14. Trail Making Test Parts A & B

    Test of Executive Function

    Measured: 3 months

  15. Trail Making Test Parts A & B

    Test of Executive Function

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2017
  2. Study start27 Mar 2017
  3. Primary completion1 Feb 2022
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
312 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03115840
Sponsor's protocol ID
116157
Other IDs
1K76AG054864-01
Acronym
MOSAIC
Status last verified
Jan 2026
First submitted
28 Mar 2017
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness and Sepsis, run by Vanderbilt University Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Precipitating Events Project Disability Questionnaire (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03115840, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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