Status:
COMPLETED
Optimizing a Mobile Mindfulness Intervention for ICU Survivors
Lead Sponsor:
Duke University
Collaborating Sponsors:
University of Washington
University of Colorado, Denver
Conditions:
Cardiorespiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a factorial experimental trial involving adult survivors of cardiorespiratory failure treated in intensive care units (ICUs) that is conceptualized as the Optimization Phase of a multiphase op...
Detailed Description
As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), it has become apparent that these patients suffer from severe and p...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Adult (age ≥18)
- Acute cardiorespiratory failure:
- Acute respiratory failure, defined as ≥1 of the following:
- mechanical ventilation via endotracheal tube for ≥12 hours
- non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure in an ICU (not for obstructive sleep apnea or other stable use)
- high flow nasal cannula or face mask oxygen for ≥4 hours in a 24-hour period and / or
- Acute cardiac / circulatory failure, defined as ≥1 of the following:
- use of vasopressors for shock of any etiology for ≥1 hour
- use of inotropes for shock of any etiology for ≥1 hour
- use of pulmonary vascular vasoactive medications
- use of aortic balloon pump for cardiogenic shock for ≥1 hour
- Managed in an adult medical cardiac, trauma, surgical, or neurological ICU, stepdown unit, or monitored ward unit for ≥24 hours during the time inclusion criterion #2 is met.
- Cognitive status intact
- No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart
- Absence of current significant cognitive impairment (impairment defined as ≥3 errors on the Callahan cognitive status screen)
- Decisional capacity present
- Absence of severe and/or persistent mental illness
- Treatment for severe and/or persistent mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia \[as per medical record\], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission
- No endorsement of suicidality at time of admission or informed consent
- No active substance abuse within the 3 months preceding the current admission serious enough to limit completion of study procedures in the opinion of the site investigator.
- English fluency.
- EXCLUSION CRITERIA (in hospital):
- Hospitalized within the preceding 3 months with life-threatening illness or injury.
- Patients may be enrolled into the study if they had a hospitalization within the preceding 3 months that is determined to be non-serious. Non-serious admissions are defined as those admissions that are non-life threatening and/or potentially impacting patient's well-being long-term or likely to precipitate additional future admissions. Examples of non-life-threatening hospitalizations could be, but may not be limited to, admission for a bronchoscopy, admission for deep vein thrombosis, or admission to ED resulting in overnight stay for cardiac work-up.
- Admitted from a location other than home (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)
- Anticipated or actual discharge to a location other than independent in a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility, home hospice)
- Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, disruptive chemotherapy/radiation regimen)
- Unable to complete study procedures as determined by staff
- Lack of reliable smartphone with cellular data plan or wifi access
- EXCLUSION CRITERIA (at T1, post-discharge):
- Low baseline psychological distress symptoms, defined as the absence of the following at T1: PHQ-9 score \<5
- Failure to randomize within 2 month (60 days) post-discharge.
Exclusion
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2023
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT04038567
Start Date
August 15 2019
End Date
July 19 2023
Last Update
August 15 2024
Active Locations (3)
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1
University of Colorado - Denver
Aurora, Colorado, United States, 80045
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
University of Washington
Seattle, Washington, United States, 98195