Measuring Outcomes of Activity in Intensive Care

Sepsis Clinical Trial

— MOSAIC  

Official title:

Long-term Outcomes of Physical Activity in Older Adults With Critical Illness

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03115840
• Other study ID #: 116157
• Secondary ID: 1K76AG054864-01
• Status: Active, not recruiting
• Start date: March 27, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 312
• Est. completion date: December 31, 2024
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. adult patients (=18 years old),

2. in a medical or surgical ICU at Vanderbilt University Medical Center or The Ohio State 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 an enrolling center and who do not regularly visit the 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

14. Confirmed or suspected COVID-19 per local guidelines at the time of screen.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Precipitating Events Project Disability Questionnaire	Questionnaire assessment of activities of daily living and mobility	12 months
Primary	Life Space Assessment Questionnaire	Questionnaire assessment of activities of community mobility	12 months
Secondary	Precipitating Events Project Disability Questionnaire	Questionnaire assessment of activities of daily living and mobility	3 months
Secondary	Life Space Assessment Questionnaire	Questionnaire assessment of activities of community mobility	3 months
Secondary	Survival	Proportion of patients surviving at 30, 90, and 365 days	30, 90, and 365 days
Secondary	Ventilator-free days	Days alive and free of mechanical ventilation	out of 28 days
Secondary	Delirium and coma-free days	Days alive and without delirium or coma	out of 28 days
Secondary	ICU Length of Stay	Days spent in the ICU during the index hospitalization	up to 28 days
Secondary	Hospital Length of Stay	Days spent in the hospital during the index hospitalization	up to 28 days
Secondary	Short Physical Performance Battery	Performance Measure of Physical Function	3 months
Secondary	Short Physical Performance Battery	Performance Measure of Physical Function	12 months
Secondary	Handgrip Dynamometry	Performance Measure of Muscle Strength	3 months
Secondary	Handgrip Dynamometry	Performance Measure of Muscle Strength	12 months
Secondary	Repeatable Battery for the Assessment of Neuropsychological Status	Test of Global Cognition	3 months
Secondary	Repeatable Battery for the Assessment of Neuropsychological Status	Test of Global Cognition	12 months
Secondary	Trail Making Test Parts A & B	Test of Executive Function	3 months
Secondary	Trail Making Test Parts A & B	Test of Executive Function	12 months