COVID-19, Cardiorespiratory Failure
Conditions
Keywords
critical illness, psychological distress, depression, anxiety, adults
Brief 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.
Detailed description
The novel coronavirus (COVID-19) pandemic has changed access to and the delivery of medical care across the world rapidly and radically as increasingly large waves of patients fill clinics, hospital wards, and intensive care units (ICUs). Patients with comparable illnesses have high rates of persistent psychological distress symptoms including depression, anxiety, and PTSD. Currently there are few easily accessible therapies available for this distress in this time of deep fear and worry, social distancing, cancelled clinics, isolation and quarantine practices, and understaffed hospitals. Lift, a novel mobile app-based mindfulness intervention, may be able to address COVID-19 patients' distress and access to care issues. Lift was piloted successfully in the intensive care unit (ICU; R34 AT00819) and is currently in the midst of a multicenter factorial experimental clinical trial designed to determine which of 8 versions is optimized for symptom relief, cost, and scalability (parent U01 AT009974). This 2-arm, parallel group randomized clinical trial seeks to expand the scope of the parent U01 project to test the clinical impact of a psychological distress intervention rapidly deployed during a pandemic. This trial will include 300 patients who were hospitalized due to COVID-19; collect data at 1, 3, and 6 months post-discharge; and address 3 specific aims: (1) Compare the clinical impact of Lift vs. usual care control and (2) Compare long-term (6-month) outcomes of RCT patients both by treatment arm as well to the entire BLUE CORAL cohort, and (3) Explore participant-reported barriers and facilitators to intervention deployment, uptake, and engagement in a pandemic.
Interventions
BEHAVIORALLift
The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Outcomes assessor will be blinded to group assignment, as will the investigators
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
BLUE CORAL eligibility (the parent cohort study from which RCT participants will be recruited) Inclusion criteria: 1. Adult hospitalized within 14 days of a positive PCR test for COVID-19 2. 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
1. Lack of informed consent 2. More than 72 hours of continuous hospitalization. 3. Comfort care orders in place at the time of enrollment and/or unexpected to survive for 24 hours 4. Prisoners 5. Previous enrollment in BLUE CORAL LIFT COVID RCT eligibility Inclusion criteria: 1. Enrolled in BLUE CORAL 2. Survival to time of BLUE CORAL 1-month post-discharge interview 2\. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 3 Months Post-discharge | T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge) | Depression symptoms. Scores range from 0 (better) to 27 (worse) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 6 Months Post-discharge | T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge) | Depression symptoms. Scores range from 0 (better) to 27 (worse) |
| Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 3 Months Post-discharge | T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge) | Anxiety symptoms. Scores range from 0 (better) to 21 (worse). |
| Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 6 Months Post-discharge | T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge) | Anxiety symptoms. Scores range from 0 (better) to 21 (worse). |
| Change in EuroQOL-5DL (Quality of Life) Scale at 3 Months Post-discharge | T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge) | EuroQOL-5DL health states can be represented by a single summary number (index value), which reflects how good or bad a health state is according to the preferences of the general population of a country/region. An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. The index is calculated by deducting the appropriate weights from 1, the value for full health. A higher index value indicates a greater health state; an increase in index value indicates an improvement in health state. The summary item can range from 0 (worst quality of life) to 100 (best quality of life). |
| Number of Participants With Cardiopulmonary Symptoms at 3 Months Post-discharge | T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge) | Cardiopulmonary symptoms such as breathlessness, fatigue, oxygen use |
| Number of Participants With Cardiopulmonary Symptoms at 6 Months Post-discharge | T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge) | Cardiopulmonary symptoms such as breathlessness, fatigue, oxygen use |
| Change in EuroQOL-5DL (Quality of Life) Scale at 6 Months Post-discharge | T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge) | EuroQOL-5DL health states can be represented by a single summary number (index value), which reflects how good or bad a health state is according to the preferences of the general population of a country/region. An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. The index is calculated by deducting the appropriate weights from 1, the value for full health. A higher index value indicates a greater health state; an increase in index value indicates an improvement in health state. The summary item can range from 0 (worst quality of life) to 100 (best quality of life). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Utilization | T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge) | Hospital readmissions and clinic visits during follow up |
| Intervention Adherence as Measured by Percentage of Tasks Completed | T3 (5 months post-randomization [i.e., 6 months post-hospital discharge) | Tasks include intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lift Mobile Mindfulness Program Will receive standard Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content.
Lift: The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period. | 29 |
| Usual Care Control Usual care. | 27 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 5 |
Baseline characteristics
| Characteristic | Usual Care Control | Total | Lift Mobile Mindfulness Program |
|---|---|---|---|
| Age, Continuous | 53.1 years STANDARD_DEVIATION 11.8 | 51.0 years STANDARD_DEVIATION 13.2 | 49.0 years STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 11 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 42 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 14 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 17 Participants | 31 Participants | 14 Participants |
| Sex: Female, Male Female | 18 Participants | 38 Participants | 20 Participants |
| Sex: Female, Male Male | 9 Participants | 18 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 |
| other Total, other adverse events | 0 / 23 | 0 / 22 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 |
Outcome results
Primary
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 3 Months Post-discharge
Depression symptoms. Scores range from 0 (better) to 27 (worse)
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)
Population: Participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lift Mobile Mindfulness Program | Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 3 Months Post-discharge | 0.09 score on a scale | Standard Deviation 3.22 |
| Usual Care Control | Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 3 Months Post-discharge | -0.50 score on a scale | Standard Deviation 4.31 |
p-value: 0.6195% CI: [-1.63, 2.8]t-test, 2 sided
Secondary
Change in EuroQOL-5DL (Quality of Life) Scale at 3 Months Post-discharge
EuroQOL-5DL health states can be represented by a single summary number (index value), which reflects how good or bad a health state is according to the preferences of the general population of a country/region. An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. The index is calculated by deducting the appropriate weights from 1, the value for full health. A higher index value indicates a greater health state; an increase in index value indicates an improvement in health state. The summary item can range from 0 (worst quality of life) to 100 (best quality of life).
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)
Population: Participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lift Mobile Mindfulness Program | Change in EuroQOL-5DL (Quality of Life) Scale at 3 Months Post-discharge | 0.02 index value | Standard Deviation 0.19 |
| Usual Care Control | Change in EuroQOL-5DL (Quality of Life) Scale at 3 Months Post-discharge | -0.03 index value | Standard Deviation 0.25 |
p-value: 0.4595% CI: [-0.57, 0.74]t-test, 2 sided
Secondary
Change in EuroQOL-5DL (Quality of Life) Scale at 6 Months Post-discharge
EuroQOL-5DL health states can be represented by a single summary number (index value), which reflects how good or bad a health state is according to the preferences of the general population of a country/region. An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. The index is calculated by deducting the appropriate weights from 1, the value for full health. A higher index value indicates a greater health state; an increase in index value indicates an improvement in health state. The summary item can range from 0 (worst quality of life) to 100 (best quality of life).
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Population: Participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lift Mobile Mindfulness Program | Change in EuroQOL-5DL (Quality of Life) Scale at 6 Months Post-discharge | 0.6 index value | Standard Deviation 0.36 |
| Usual Care Control | Change in EuroQOL-5DL (Quality of Life) Scale at 6 Months Post-discharge | 0.66 index value | Standard Deviation 0.28 |
p-value: 0.9895% CI: [-0.13, 0.13]t-test, 2 sided
Secondary
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 3 Months Post-discharge
Anxiety symptoms. Scores range from 0 (better) to 21 (worse).
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)
Population: Participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lift Mobile Mindfulness Program | Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 3 Months Post-discharge | 0.09 score on a scale | Standard Deviation 4.76 |
| Usual Care Control | Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 3 Months Post-discharge | -0.27 score on a scale | Standard Deviation 5.29 |
p-value: 0.8195% CI: [-2.58, 3.3]t-test, 2 sided
Secondary
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 6 Months Post-discharge
Anxiety symptoms. Scores range from 0 (better) to 21 (worse).
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Population: Data not collected on 4 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lift Mobile Mindfulness Program | Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 6 Months Post-discharge | 0.26 score on a scale | Standard Deviation 4.83 |
| Usual Care Control | Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 6 Months Post-discharge | 0.68 score on a scale | Standard Deviation 4.57 |
p-value: 0.7595% CI: [-2.98, 2.14]t-test, 2 sided
Secondary
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 6 Months Post-discharge
Depression symptoms. Scores range from 0 (better) to 27 (worse)
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Population: Data not collected on 4 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lift Mobile Mindfulness Program | Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 6 Months Post-discharge | -0.63 score on a scale | Standard Deviation 5.76 |
| Usual Care Control | Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 6 Months Post-discharge | -0.84 score on a scale | Standard Deviation 4.71 |
p-value: 0.8995% CI: [-2.66, 3.08]t-test, 2 sided
Secondary
Number of Participants With Cardiopulmonary Symptoms at 3 Months Post-discharge
Cardiopulmonary symptoms such as breathlessness, fatigue, oxygen use
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)
Population: Participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lift Mobile Mindfulness Program | Number of Participants With Cardiopulmonary Symptoms at 3 Months Post-discharge | 10 Participants |
| Usual Care Control | Number of Participants With Cardiopulmonary Symptoms at 3 Months Post-discharge | 4 Participants |
p-value: 0.08Fisher Exact
Secondary
Number of Participants With Cardiopulmonary Symptoms at 6 Months Post-discharge
Cardiopulmonary symptoms such as breathlessness, fatigue, oxygen use
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Population: Participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lift Mobile Mindfulness Program | Number of Participants With Cardiopulmonary Symptoms at 6 Months Post-discharge | 8 Participants |
| Usual Care Control | Number of Participants With Cardiopulmonary Symptoms at 6 Months Post-discharge | 9 Participants |
p-value: 0.69Fisher Exact
Other Pre-specified
Healthcare Utilization
Hospital readmissions and clinic visits during follow up
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Population: Data not collected.
Other Pre-specified
Intervention Adherence as Measured by Percentage of Tasks Completed
Tasks include intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio).
Time frame: T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Population: Not applicable to the usual care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lift Mobile Mindfulness Program | Intervention Adherence as Measured by Percentage of Tasks Completed | 23.0 percentage of tasks completed | Standard Deviation 29.3 |