Measuring Outcomes of Activity in Intensive Care (MOSAIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03115840|
Recruitment Status : Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : April 12, 2023
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|Condition or disease|
|Critical Illness Sepsis Mechanical Ventilation Physical Activity Disability Physical Muscle Weakness Cognitive Impairment|
|Study Type :||Observational|
|Estimated Enrollment :||312 participants|
|Official Title:||Long-term Outcomes of Physical Activity in Older Adults With Critical Illness|
|Actual Study Start Date :||March 27, 2017|
|Actual Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||December 31, 2023|
|Adults (≥18 years old) with critical illness|
- 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
- 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
Biospecimen Retention: Samples With DNA
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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|
- 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.
- 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).
- 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.
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
|United States, Ohio|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37212|
|Responsible Party:||Rebecca Abel, Professor of Medicine, Allergy/Pulmonary & Critical Care, Vanderbilt University Medical Center|
|Other Study ID Numbers:||
1K76AG054864-01 ( U.S. NIH Grant/Contract )
|First Posted:||April 14, 2017 Key Record Dates|
|Last Update Posted:||April 12, 2023|
|Last Verified:||April 2023|
|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|
Nervous System Diseases