- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03115840
Measuring Outcomes of Activity in Intensive Care (MOSAIC)
January 19, 2024 updated by: Wes Ely, Vanderbilt University Medical Center
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.
Study Overview
Status
Active, not recruiting
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.
Study Type
Observational
Enrollment (Estimated)
312
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients with medical or surgical critical illness
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Adults (≥18 years old) with critical illness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Precipitating Events Project Disability Questionnaire
Time Frame: 12 months
|
Questionnaire assessment of activities of daily living and mobility
|
12 months
|
Life Space Assessment Questionnaire
Time Frame: 12 months
|
Questionnaire assessment of activities of community mobility
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Precipitating Events Project Disability Questionnaire
Time Frame: 3 months
|
Questionnaire assessment of activities of daily living and mobility
|
3 months
|
Life Space Assessment Questionnaire
Time Frame: 3 months
|
Questionnaire assessment of activities of community mobility
|
3 months
|
Survival
Time Frame: 30, 90, and 365 days
|
Proportion of patients surviving at 30, 90, and 365 days
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30, 90, and 365 days
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Ventilator-free days
Time Frame: out of 28 days
|
Days alive and free of mechanical ventilation
|
out of 28 days
|
Delirium and coma-free days
Time Frame: out of 28 days
|
Days alive and without delirium or coma
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out of 28 days
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ICU Length of Stay
Time Frame: up to 28 days
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Days spent in the ICU during the index hospitalization
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up to 28 days
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Hospital Length of Stay
Time Frame: up to 28 days
|
Days spent in the hospital during the index hospitalization
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up to 28 days
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Short Physical Performance Battery
Time Frame: 3 months
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Performance Measure of Physical Function
|
3 months
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Short Physical Performance Battery
Time Frame: 12 months
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Performance Measure of Physical Function
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12 months
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Handgrip Dynamometry
Time Frame: 3 months
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Performance Measure of Muscle Strength
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3 months
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Handgrip Dynamometry
Time Frame: 12 months
|
Performance Measure of Muscle Strength
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12 months
|
Repeatable Battery for the Assessment of Neuropsychological Status
Time Frame: 3 months
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Test of Global Cognition
|
3 months
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Repeatable Battery for the Assessment of Neuropsychological Status
Time Frame: 12 months
|
Test of Global Cognition
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12 months
|
Trail Making Test Parts A & B
Time Frame: 3 months
|
Test of Executive Function
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3 months
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Trail Making Test Parts A & B
Time Frame: 12 months
|
Test of Executive Function
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12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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. Erratum In: JAMA. 2011 Apr 6;305(13):1301.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 27, 2017
Primary Completion (Actual)
February 1, 2022
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
March 28, 2017
First Submitted That Met QC Criteria
April 11, 2017
First Posted (Actual)
April 14, 2017
Study Record Updates
Last Update Posted (Actual)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 19, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 116157
- 1K76AG054864-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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