Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT04038567
Eligibility Criteria:
INCLUSION CRITERIA
1. Adult (age ≥18)
2. 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
3. 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.
4. 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
5. 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.
6. English fluency.
EXCLUSION CRITERIA (in hospital):
1. 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.
2. Admitted from a location other than home (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)
3. 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)
4. Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, disruptive chemotherapy/radiation regimen)
5. Unable to complete study procedures as determined by staff
6. Lack of reliable smartphone with cellular data plan or wifi access
EXCLUSION CRITERIA (at T1, post-discharge):
7. Low baseline psychological distress symptoms, defined as the absence of the following at T1: PHQ-9 score \<5
8. Failure to randomize within 2 month (60 days) post-discharge.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04038567
Study Brief:
Protocol Section:
NCT04038567