Clinical trial NCT05119400: COVID-19 (Coronavirus Disease-2019) Psychiatric Outcomes
Official title: Psychiatric Outcomes Following Inpatient Hospitalization For COVID-19
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Covid19
Anxiety
Mood
Cognitive Impairment
Keywords: Psychiatric Outcome
Inpatient Hospitalization
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients who were previously hospitalized at NYP/WCM between March 1 and December 31, 2020 for a minimum of three days will be enrolled.

Out of 60, 30 patients would have a past diagnosis of COVID-19 and 30 patients would have undergone hospitalization secondary to a medical diagnosis that was not COVID-19.

Brief summary: The goal of this longitudinal and observational study is to better understand the psychiatric consequences of COVID-19 over time. Psychiatric outcomes like mood, anxiety, stress, and cognitive symptoms in patients who underwent inpatient hospitalization at NewYork-Presbyterian Hospital/Weill Cornell Medicine for COVID-19 will be assessed at 6 months or later post-discharge.


Eligibility criteria: Inclusion Criteria-COVID-19 group:

* Men and women age 18-89.
* Past diagnosis of COVID-19 with confirmed positive SARS-CoV-2 PCR test in electronic medical record
* English speaking
* Previously hospitalized at NYP/WCM between March 1 2020 and six months prior to enrollment for a minimum of three days.

Inclusion Criteria-Comparison group:

* Men and women age 18-89
* English speaking
* Previously hospitalized at NYP/WCM between March 1 2020 and six months prior to enrollment for a minimum of three days.
* Underwent hospitalization secondary to a medical diagnosis that was not COVID-19

Exclusion Criteria--COVID-19 group:

N/A

Exclusion Criteria--Comparison group:

* Past diagnosis of COVID-19
* Admitted to inpatient hospitalization due to, or past history of, a primary central nervous system relation etiology such as stroke, brain tumor, encephalitis, traumatic brain injury, multiple sclerosis, or Parkinson's disease.

Primary outcomes:
measure: Cognitive functioning as measured by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (English)
timeFrame: Once, 6 months to 36 months post-discharge from the hospital.
Secondary outcomes:
measure: Executive functioning as measured by the Oral Trail Making Test-B (OTMT-B; English)
timeFrame: Once, 6 months to 36 months post-discharge from the hospital.
measure: Cognitive control as measured by the Stroop test (English)
timeFrame: Once, 6 months to 36 months post-discharge from the hospital.
measure: Verbal intellectual ability as measured by the National Adult Reading Test (NART) for English speakers and the Word Accentuation Test (WAT).
timeFrame: Once, 6 months to 36 months post-discharge from the hospital.
measure: Verbal Fluency (English)
timeFrame: Once, 6 months to 36 months post-discharge from the hospital.
measure: Mood symptoms as assessed by DASS (English)
timeFrame: Once, 6 months to 36 months post-discharge from the hospital.
measure: Mood symptoms as assessed by PANAS (English)
timeFrame: Once, 6 months to 36 months post-discharge from the hospital.
measure: Acceptance as assessed by AAQ-II (English)
timeFrame: Once, 6 months to 36 months post-discharge from the hospital.
measure: Resilience as assessed by Brief Resilience Scale (English)
timeFrame: Once, 6 months to 36 months post-discharge from the hospital.
measure: Cognitive difficulties in daily life as assessed by Neuro Quality of Life (NeuroQOL) (English)
timeFrame: Once, 6 months to 36 months post-discharge from the hospital.
measure: Cognitive function as assessed by Attention Network Test (ANT)
timeFrame: Once, 6 months to 36 months post-discharge from the hospital.
measure: Cognitive function as assessed by EEG.
timeFrame: Once, 6 months to 36 months post-discharge from the hospital.
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Abhishek Jaywant, PhD
role: PRINCIPAL_INVESTIGATOR
References: