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Measuring Outcomes of Activity in Intensive Care (MOSAIC)

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ClinicalTrials.gov Identifier: NCT03115840
Recruitment Status : Suspended (Study enrollment halted due to COVID-19)
First Posted : April 14, 2017
Last Update Posted : July 27, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wes Ely, Vanderbilt University Medical Center

Tracking Information
First Submitted Date March 28, 2017
First Posted Date April 14, 2017
Last Update Posted Date July 27, 2020
Actual Study Start Date March 27, 2017
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2017)
  • Precipitating Events Project Disability Questionnaire [ Time Frame: 12 months ]
    Questionnaire assessment of activities of daily living and mobility
  • Life Space Assessment Questionnaire [ Time Frame: 12 months ]
    Questionnaire assessment of activities of community mobility
Original Primary Outcome Measures
 (submitted: April 11, 2017)
  • Disability in Activities of Daily Living and Mobility [ Time Frame: 12 months ]
    Precipitating Events Project Disability Questionnaire
  • Disability in Mobility [ Time Frame: 12 months ]
    Life Space Assessment Questionnaire
Change History
Current Secondary Outcome Measures
 (submitted: April 21, 2017)
  • Precipitating Events Project Disability Questionnaire [ Time Frame: 3 months ]
    Questionnaire assessment of activities of daily living and mobility
  • Life Space Assessment Questionnaire [ Time Frame: 3 months ]
    Questionnaire assessment of activities of community mobility
  • Survival [ Time Frame: 30, 90, and 365 days ]
    Proportion of patients surviving at 30, 90, and 365 days
  • Ventilator-free days [ Time Frame: out of 28 days ]
    Days alive and free of mechanical ventilation
  • Delirium and coma-free days [ Time Frame: out of 28 days ]
    Days alive and without delirium or coma
  • ICU Length of Stay [ Time Frame: up to 28 days ]
    Days spent in the ICU during the index hospitalization
  • Hospital Length of Stay [ Time Frame: up to 28 days ]
    Days spent in the hospital during the index hospitalization
  • Short Physical Performance Battery [ Time Frame: 3 months ]
    Performance Measure of Physical Function
  • Short Physical Performance Battery [ Time Frame: 12 months ]
    Performance Measure of Physical Function
  • Handgrip Dynamometry [ Time Frame: 3 months ]
    Performance Measure of Muscle Strength
  • Handgrip Dynamometry [ Time Frame: 12 months ]
    Performance Measure of Muscle Strength
  • Repeatable Battery for the Assessment of Neuropsychological Status [ Time Frame: 3 months ]
    Test of Global Cognition
  • Repeatable Battery for the Assessment of Neuropsychological Status [ Time Frame: 12 months ]
    Test of Global Cognition
  • Trail Making Test Parts A & B [ Time Frame: 3 months ]
    Test of Executive Function
  • Trail Making Test Parts A & B [ Time Frame: 12 months ]
    Test of Executive Function
Original Secondary Outcome Measures
 (submitted: April 11, 2017)
  • Disability in Activities of Daily Living and Mobility [ Time Frame: 3 months ]
    Precipitating Events Project Disability Questionnaire
  • Disability in Mobility [ Time Frame: 3 months ]
    Life Space Assessment Questionnaire
  • Survival [ Time Frame: 30, 90, and 365 days ]
    Proportion of patients surviving at 30, 90, and 365 days
  • Ventilator-free days [ Time Frame: out of 28 days ]
    Days alive and free of mechanical ventilation
  • Delirium and coma-free days [ Time Frame: out of 28 days ]
    Days alive and without delirium or coma
  • ICU Length of Stay [ Time Frame: up to 28 days ]
    Days spent in the ICU during the index hospitalization
  • Hospital Length of Stay [ Time Frame: up to 28 days ]
    Days spent in the hospital during the index hospitalization
  • Physical Function [ Time Frame: 3 months ]
    Short Physical Performance Battery
  • Physical Function [ Time Frame: 12 months ]
    Short Physical Performance Battery
  • Muscle Strength [ Time Frame: 3 months ]
    Handgrip Dynamometry
  • Muscle Strength [ Time Frame: 12 months ]
    Handgrip Dynamometry
  • Global Cognition [ Time Frame: 3 months ]
    Repeatable Battery for the Assessment of Neuropsychological Status
  • Global Cognition [ Time Frame: 12 months ]
    Repeatable Battery for the Assessment of Neuropsychological Status
  • Executive Function [ Time Frame: 3 months ]
    Trail Making Test Parts A & B
  • Executive Function [ Time Frame: 12 months ]
    Trail Making Test Parts A & B
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measuring Outcomes of Activity in Intensive Care
Official Title Long-term Outcomes of Physical Activity in Older Adults With Critical Illness
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
Sampling Method Non-Probability Sample
Study Population Adult patients with medical or surgical critical illness
Condition
  • Critical Illness
  • Sepsis
  • Mechanical Ventilation
  • Physical Activity
  • Disability Physical
  • Muscle Weakness
  • Cognitive Impairment
Intervention Not Provided
Study Groups/Cohorts Adults (≥18 years old) with critical illness
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: April 11, 2017)
312
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03115840
Other Study ID Numbers 116157
1K76AG054864-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Wes Ely, Vanderbilt University Medical Center
Study Sponsor Vanderbilt University Medical Center
Collaborators National Institute on Aging (NIA)
Investigators Not Provided
PRS Account Vanderbilt University Medical Center
Verification Date July 2020