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Psychological Symptoms and Families of COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04501445
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Central Michigan University
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:

Families of patients in Intensive Care Units (ICUs) are at increased risk for developing psychological symptoms that can last for months after the patient is discharged. These symptoms can have significant impact on both the patient and family member's quality of life.

The investigators have found that families of patients admitted to the Rush University Medical Center ICU during to the COVID-19 pandemic were more likely to develop clinically significant psychological symptoms than families of patients admitted prior to the COVID-19 pandemic. The investigators suspect that this finding is due in part to the hospital-wide no visitation policy that altered our standard communication practices and may have prevented families from being active participants in the patient's medical care.

The goals of this project are 1) to determine the prevalence of psychological disorders among families of COVID-19 patients after ICU discharge 2) to determine the characteristics of ICU care that were associated with the development of psychological disorders among family members and 3) to pilot a program in which families with psychological disorders after ICU discharge receive therapy from mental health professionals.


Condition or disease Intervention/treatment Phase
Family Members Post Intensive Care Unit Syndrome Post Traumatic Stress Disorder Behavioral: Written Summary of Rounds Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Relieving the Burden of Psychological Symptoms Among Families of Critically Ill Patients With COVID-19
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : September 15, 2021

Arm Intervention/treatment
Experimental: Rounding Summary
Surrogates who were assigned to the intervention group received a written rounding summary every day or every other day that the patient is in the ICU.
Behavioral: Written Summary of Rounds
The summary was organized as follows for each of the most important ICU problems: 1) Description of the problem, 2) Ways the ICU team is addressing the problem i.e. consultations, diagnostic tests, and treatments. 3) An assessment of whether the problem is improving or worsening.

No Intervention: Usual Care



Primary Outcome Measures :
  1. Symptoms of Post-Traumatic Stress Disorder (PTSD) initial [ Time Frame: Measured once upon enrollment ]
    Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.

  2. Symptoms of Anxiety and Depression initial [ Time Frame: Measured once upon enrollment ]
    Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.


Secondary Outcome Measures :
  1. Surrogate Satisfaction with the Patient's ICU Care: [ Time Frame: Measured once upon enrollment ]
    Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.

  2. Symptoms of Post-Traumatic Stress Disorder (PTSD) final [ Time Frame: Measured after behavioral intervention (6-12 weeks after enrollment) ]
    Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.

  3. Symptoms of Anxiety and Depression final [ Time Frame: Measured after behavioral intervention (6-12 weeks after enrollment) ]
    Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.

  4. Interview initial [ Time Frame: Measured once upon enrollment ]
    Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms

  5. Interview final [ Time Frame: Measured after behavioral intervention (6-12 weeks after enrollment) ]
    Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient's surrogate was enrolled in "ICU Rounding Summaries for Families of Critically Ill Patients" (NCT03969810) and the patient had COVID-19
  • The patient has been discharged from the hospital

Exclusion Criteria:

- None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04501445


Contacts
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Contact: Jared A Greenberg 312-942-7871 jared_greenberg@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Jared A Greenberg, MD    312-942-6744    jared_greenberg@rush.edu   
Sponsors and Collaborators
Rush University Medical Center
Central Michigan University
Publications:
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04501445    
Other Study ID Numbers: 20071101
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders