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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT04329702
Eligibility Criteria:
INCLUSION CRITERIA
1. Adult (age ≥18)
2. Managed in a hospital setting for ≥24 hours during the time inclusion criterion #3 is met.
3. Acute cardiorespiratory failure / insufficiency, defined as ≥1 of the following:
* mechanical ventilation via endotracheal tube for ≥4 hours
* non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure
* new use of supplemental oxygen ≥2 liters per minute (or increase in baseline continuous oxygen)
* use of vasopressors for shock of any etiology
* use of inotropes for shock of any etiology
* use of pulmonary vasodilators
* use of aortic balloon pump or cardiac assist device for cardiogenic shock
* use of diuretic intravenous drip
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 active suicidality at time of admission or informed consent
* No active substance abuse at a severity that impairs ability to participate
6. Functional English fluency
EXCLUSION CRITERIA (in hospital):
1. Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for follow up care, disruptive chemotherapy/radiation regimen)
2. Unable to complete study procedures as determined by staff
3. Lack of access to either reliable smartphone with cellular data plan or wifi
INCLUSION CRITERIA (post-discharge)
1\. Elevated baseline (T1) psychological distress symptoms, defined as HADS total score of ≥8
EXCLUSION CRITERIA (post-discharge)
1. Failure to randomize within 2 months post-discharge.
2. Failure to access app within 1 month after randomization in the absence of other explanation (e.g., hospitalization).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04329702
Study Brief:
Protocol Section:
NCT04329702