Phase
Condition
Stress
Post-traumatic Stress Disorders
Panic Disorders
Treatment
Blueprint
Education program
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria Inclusion criteria present in the hospital
Adult (age ≥18)
Managed in an ICU or stepdown unit for ≥24 hours during the time inclusion criterion
#3 is met
- Serious acute cardiorespiratory condition, 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 ≥6 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
evidence of acute coronary ischemia (i.e., elevated troponin level, supporting EKG changes, unstable angina symptoms documented)
urgent cardiac catheterization
- Cognitive status intact
• No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart
- Absence of severe mental illness
Treatment for severe 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
Evidence of poorly managed severe mental illness
No endorsement of suicidality at time of admission or informed consent
- Functional fluency in English or Spanish (i.e., sufficient knowledge of English or Spanish to complete study tasks like watch videos, complete surveys)
Inclusion criteria present after hospital discharge (i.e., at the time of arrival home after discharge from the hospital)
- Elevated baseline psychological distress symptoms, defined as a Hospital Anxiety and Distress Scale (HADS) total score ≥8
Exclusion Criteria Exclusion criteria present in the hospital
Active alcohol or drug abuse (e.g., admission for alcohol withdrawal, drug-related complication, positive toxicology screening at admission, endorsement of active addiction)
Anticipated complex medical needs after discharge that would be disruptive to intervention and follow up; for example:
Anticipated surgical procedures
Anticipated complex medical regiment (e.g., new chemotherapy, new dialysis, need for repeat surgery, pregnant and near term)
Plan for comfort care
- Other complex needs anticipated that could interfere with the ability to complete study procedures. Examples include:
Anticipated disruptive travel
Inability to use mobile app
Anticipated unstable living situation
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)
Persistently impaired cognition as a result of illness (Impairment defined as ≥3 errors on the Callahan cognitive status screen and/or the lack of decisional capacity (i.e., patient could be consented by medical team for a procedure if necessary)
Currently imprisoned or incarcerated or in home detention
Lack a reliable smartphone with cellular data plan or access to the internet
Currently enrolled in another study involving an intervention whose objectives conflict with the objectives of this study
Previously enrolled in the trial
Exclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital)
Failure to randomize within 14 days from planned start date (planned start date is within 3 days post-discharge from the hospital to home to accommodate weekends)
Readmission to hospital before randomization completed
Study Design
Study Description
Connect with a study center
Duke University Medical Center
Durham, North Carolina 27710
United StatesActive - Recruiting
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