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Measuring Outcomes of Activity in Intensive Care (MOSAIC)

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ClinicalTrials.gov Identifier: NCT03115840
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Nathan Brummel, 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.

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

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
Estimated Enrollment : 312 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Outcomes of Physical Activity in Older Adults With Critical Illness
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2021

Group/Cohort
Adult patients (≥18 years old) critical illness



Primary Outcome Measures :
  1. Precipitating Events Project Disability Questionnaire [ Time Frame: 12 months ]
    Questionnaire assessment of activities of daily living and mobility

  2. Life Space Assessment Questionnaire [ Time Frame: 12 months ]
    Questionnaire assessment of activities of community mobility


Secondary Outcome Measures :
  1. Precipitating Events Project Disability Questionnaire [ Time Frame: 3 months ]
    Questionnaire assessment of activities of daily living and mobility

  2. Life Space Assessment Questionnaire [ Time Frame: 3 months ]
    Questionnaire assessment of activities of community mobility

  3. Survival [ Time Frame: 30, 90, and 365 days ]
    Proportion of patients surviving at 30, 90, and 365 days

  4. Ventilator-free days [ Time Frame: out of 28 days ]
    Days alive and free of mechanical ventilation

  5. Delirium and coma-free days [ Time Frame: out of 28 days ]
    Days alive and without delirium or coma

  6. ICU Length of Stay [ Time Frame: up to 28 days ]
    Days spent in the ICU during the index hospitalization

  7. Hospital Length of Stay [ Time Frame: up to 28 days ]
    Days spent in the hospital during the index hospitalization

  8. Short Physical Performance Battery [ Time Frame: 3 months ]
    Performance Measure of Physical Function

  9. Short Physical Performance Battery [ Time Frame: 12 months ]
    Performance Measure of Physical Function

  10. Handgrip Dynamometry [ Time Frame: 3 months ]
    Performance Measure of Muscle Strength

  11. Handgrip Dynamometry [ Time Frame: 12 months ]
    Performance Measure of Muscle Strength

  12. Repeatable Battery for the Assessment of Neuropsychological Status [ Time Frame: 3 months ]
    Test of Global Cognition

  13. Repeatable Battery for the Assessment of Neuropsychological Status [ Time Frame: 12 months ]
    Test of Global Cognition

  14. Trail Making Test Parts A & B [ Time Frame: 3 months ]
    Test of Executive Function

  15. Trail Making Test Parts A & B [ Time Frame: 12 months ]
    Test of Executive Function


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with medical or surgical critical illness
Criteria

Inclusion Criteria:

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

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 Nashville and who do not regularly visit the Nashville 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115840


Contacts
Contact: Nathan E Brummel, MD, MSCI 615-343-3957 nathan.brummel@vanderbilt.edu
Contact: E. Wesley Ely, MD, MPH 615-936-3395 wes.ely@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Nathan E Brummel, MD, MSCI    615-343-3957    nathan.brummel@vanderbilt.edu   
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute on Aging (NIA)

Publications:
Responsible Party: Nathan Brummel, Assistant Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03115840     History of Changes
Other Study ID Numbers: 116157
1K76AG054864-01 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Cognitive Dysfunction
Critical Illness
Muscle Weakness
Paresis
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms