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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT03431493
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years old
* Living at home before the current admission (not in a facility)
* Acute respiratory failure managed in the ICU \> 24hrs (≥1 of the following):
1. Mechanical ventilation via an endotracheal tube or tracheostomy \> 12hrs (and not ventilator-dependent before admission) OR
2. Non-invasive ventilation (CPAP, BiPAP) \> 4 hours in a 24 hour period provided for acute respiratory failure (not for Obstructive Sleep Apnoea (OSA) or other stable use) OR
3. High flow nasal cannula with Fraction of Inspired Oxygen (FiO2) ≥ 0.5 for ≥4 hours in a 24hr period
* At least mild depressive symptoms (score ≥2 on PHQ-2 scale)
Exclusion Criteria:
* Pre-existing cognitive impairment (based on review of medical records, or proxy- administered Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score \>3.3)
* Declines informed consent or not capable of providing informed consent
* Non-English speaking
* Homelessness or living \>50 miles away from study site
* Bedbound prior to the current admission
* Expected survival \< 6 months according to ICU attending
* ICU Length Of Stay (LOS) \> 30 days
* Not discharged home from the hospital
* Complex medical care expected soon after discharge (e.g. multiple planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, chemotherapy or radiation therapy, etc)
* Active substance abuse or psychosis
* Lack of access to telephone or inability to use telephone independently
* Pregnancy
* Suicidality
* Incarcerated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03431493
Study Brief:
Protocol Section:
NCT03431493