Measuring Outcomes of Activity in Intensive Care

NCT03115840 | Active Not Recruiting

• 2 other identifiers: 1161571K76AG054864-01
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 2

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.

Conditions

Mechanical Ventilation; Physical Activity; Disability Physical; Muscle Weakness; Cognitive Impairment; Critical Illness; Sepsis

Outcome Measures

Primary Outcomes (2)

• Precipitating Events Project Disability Questionnaire

  Questionnaire assessment of activities of daily living and mobility

  12 months

• Life Space Assessment Questionnaire

  Questionnaire assessment of activities of community mobility

  12 months

Secondary Outcomes (15)

• Precipitating Events Project Disability Questionnaire

  3 months

• Life Space Assessment Questionnaire

  3 months

• Survival

  30, 90, and 365 days

• Ventilator-free days

  out of 28 days

• Delirium and coma-free days

  out of 28 days

Study Arms (1)

Adults (≥18 years old) with critical illness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with medical or surgical critical illness

You may qualify if:

• 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.

You may not qualify if:

• 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
• Attending physician refusal
• Patient and/or surrogate refusal
• hour period of eligibility was exceeded before the patient was screened
• Confirmed or suspected COVID-19 per local guidelines at the time of screen.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (4)

• 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.

  PMID: 25756418 BACKGROUND

• 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.

  PMID: 24088092 BACKGROUND

• 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.

  PMID: 21470008 BACKGROUND

• 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.

  PMID: 21045098 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Critical Illness; Sepsis; Motor Activity; Muscle Weakness; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Behavior; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Allergy/Pulmonary & Critical Care

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 14, 2017
• Study Start: March 27, 2017
• Primary Completion: February 1, 2022
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)