Status:
COMPLETED
Mobile Coping Skills Training to Improve Cardiorespiratory Failure Survivors' Psychological Distress
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiorespiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a pilot randomized clinical trial involving adult survivors of cardiorespiratory failure treated in intensive care units (ICUs) that is designed to test the acceptability, feasibility, and cli...
Detailed Description
As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), research has clarified how these survivors suffer from severe and p...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Adult (age ≥18)
- Managed in a hospital setting for ≥24 hours during the time inclusion criterion #3 is met.
- 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
- 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 active suicidality at time of admission or informed consent
- No active substance abuse at a severity that impairs ability to participate
- Functional English fluency
- EXCLUSION CRITERIA (in hospital):
- Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for follow up care, disruptive chemotherapy/radiation regimen)
- Unable to complete study procedures as determined by staff
- 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)
- Failure to randomize within 2 months post-discharge.
- Failure to access app within 1 month after randomization in the absence of other explanation (e.g., hospitalization).
Exclusion
Key Trial Info
Start Date :
December 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04329702
Start Date
December 3 2020
End Date
March 31 2022
Last Update
February 3 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Medical Center
Durham, North Carolina, United States, 27710