N/A
N=56
Lift Mobile Mindfulness for COVID-19 Distress Symptoms
COVID-19 · Cardiorespiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT04581200 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 3 Months Post-discharge — 0.09; -0.50 score on a scale — p=0.61
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lift (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 3 Months Post-discharge |
0.09; -0.50 | 0.61 |
| SECONDARY Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 6 Months Post-discharge |
-0.63; -0.84 | 0.89 |
| SECONDARY Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 3 Months Post-discharge |
0.09; -0.27 | 0.81 |
| SECONDARY Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 6 Months Post-discharge |
0.26; 0.68 | 0.75 |
| SECONDARY Change in EuroQOL-5DL (Quality of Life) Scale at 3 Months Post-discharge |
0.02; -0.03 | 0.45 |
| SECONDARY Change in EuroQOL-5DL (Quality of Life) Scale at 6 Months Post-discharge |
0.6; 0.66 | 0.98 |
| SECONDARY Number of Participants With Cardiopulmonary Symptoms at 3 Months Post-discharge |
10; 4 | 0.08 |
| SECONDARY Number of Participants With Cardiopulmonary Symptoms at 6 Months Post-discharge |
8; 9 | 0.69 |
Summary
This is a randomized clinical trial (RCT) nested within the NIH PETAL Network's COVID cohort study (BLUE CORAL [Biology and Longitudinal Epidemiology: COVID Observational Study]) of patients hospitalized for COVID-19-related illness. COVID-19 patients enrolled in BLUE CORAL with elevated distress symptoms 1 month post-discharge will be randomized to either the Lift mobile app intervention or a usual care control.
Eligibility Criteria
BLUE CORAL eligibility (the parent cohort study from which RCT participants will be recruited)
Inclusion criteria
- Adult hospitalized within 14 days of a positive PCR test for COVID-19
- Evidence of acute COVID-19, with fever or respiratory manifestations, as characterized by signs and symptoms such as cough, dyspnea, tachypnea, hypoxemia, and infiltrates on chest imaging.
Exclusion criteria
- Lack of informed consent
- More than 72 hours of continuous hospitalization.
- Comfort care orders in place at the time of enrollment and/or unexpected to survive for 24 hours
- Prisoners
- Previous enrollment in BLUE CORAL
LIFT COVID RCT eligibility
Inclusion criteria
- Enrolled in BLUE CORAL
- Survival to time of BLUE CORAL 1-month post-discharge interview
- English-speaking 3. Domiciled with access to a working telephone and smartphone, tablet, or computer with wifi or internet connection 4. Absence of severe dementia or cognitive dysfunction either before hospitalization or at time of 1 month post-discharge interview
Exclusion criteria
- PHQ-9 <5 at time of interview 1 month post-discharge
- Suicidal ideation at time of interview 1 month post-discharge
Data sourced from ClinicalTrials.gov (NCT04581200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.