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Psychological Well-being of Patients Awaiting for Cardiac Surgery During the COVID-19 Pandemic

Primary Purpose

Anxiety and Fear, Anxiety Depression, Anxiety Postoperative

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

HADS

a survey

About this trial

This is an interventional supportive care trial for Anxiety and Fear focused on measuring cardiac surgery, postoperative consultation, postponed elective surgery, COVID-19

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All adult patients whose operation date has been deferred due to the pandemic COVID-19.

All patients who did not have had an operation date before the pandemic COVID-19.

All patients who have been operating on during the month before the pandemic COVID-19.

Exclusion Criteria:

N/A

Sites / Locations

universitair Ziekenhuis BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

operation deferred

no operation date

postoperative consultation deferred

Arm Description

Adult patients whose operation date has been deferred due to the pandemic

Patients who did not have had an operation date and who were told to need cardiac surgery before the pandemic started

Patients who have been operating on during the month before the pandemic

Outcomes

Primary Outcome Measures

Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS)

The degree of anxiety and/or depression in all three groups, induced by their altered medical care trajectory. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit

The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.

Reduced access to medical and psychological help

The occurrence of reduced access to medical and psychological help by means of an adjusted survey.

Secondary Outcome Measures

Full Information

NCT ID

NCT04406181

First Posted

April 28, 2020

Last Updated

May 28, 2020

Sponsor

Universitair Ziekenhuis Brussel

1. Study Identification

Unique Protocol Identification Number

NCT04406181

Brief Title

Psychological Well-being of Patients Awaiting for Cardiac Surgery During the COVID-19 Pandemic

Official Title

Effect on the COVID-19 Pandemic-induced Reduction in Elective Surgery on Medical Events and Psychological Well-being of Patients Waiting for Cardiac Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 18, 2020 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The effect and impact of postponing cardiac surgery / creating a waiting list as a result of COVID-19 on patients, both psychologically and symptomatically on three groups of patients: The degree of anxiety and/or depression induced by their altered medical care trajectory. The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit The occurrence of reduced access to medical and psychological help

Detailed Description

A prospective study by means of a questionnaire, specifically designed for each of the three groups. Adult patients whose operation date has been deferred Patients who did not have had an operation date Patients who have been operating on during the month before Each group will receive a twofold questionnaire: Part I: Hospital Anxiety and Depression Scale (HADS), a robust questionnaire used for hospitalized and non-hospitalized patients gauging the degree of anxiety and/or depression, irrespective of their specific medical condition. All three groups receive the same list of questions. -Part II: a questionnaire made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak. Each of the three groups will receive a questionnaire, adapted to the group they are assigned to. The questionnaires will be delivered by the use of Qualtrics or on paper. Timing and mode of presentation (Qualtrics or fill-in paper on admission) of the questionnaire will depend on the length of the quarantine measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety and Fear, Anxiety Depression, Anxiety Postoperative, Psychological Stress

Keywords

cardiac surgery, postoperative consultation, postponed elective surgery, COVID-19

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

operation deferred

Arm Type

Other

Arm Description

Adult patients whose operation date has been deferred due to the pandemic

Arm Title

no operation date

Arm Type

Other

Arm Description

Patients who did not have had an operation date and who were told to need cardiac surgery before the pandemic started

Arm Title

postoperative consultation deferred

Arm Type

Other

Arm Description

Patients who have been operating on during the month before the pandemic

Intervention Type

Behavioral

Intervention Name(s)

HADS

Other Intervention Name(s)

questionnaire

Intervention Description

Hospital Anxiety and Depression Scale

Intervention Type

Behavioral

Intervention Name(s)

a survey

Intervention Description

made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak

Primary Outcome Measure Information:

Title

Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS)

Description

The degree of anxiety and/or depression in all three groups, induced by their altered medical care trajectory. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

Time Frame

10 minutes

Title

Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit

Description

The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.

Time Frame

10 minutes

Title

Reduced access to medical and psychological help

Description

The occurrence of reduced access to medical and psychological help by means of an adjusted survey.

Time Frame

10 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All adult patients whose operation date has been deferred due to the pandemic COVID-19. All patients who did not have had an operation date before the pandemic COVID-19. All patients who have been operating on during the month before the pandemic COVID-19. Exclusion Criteria: N/A

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Veerle Van Mossevelde, Data Nurse

Phone

+3224763134

veerle.vanmossevelde@uzbrussel.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Nijs, MD

Organizational Affiliation

Universitair Ziekenhuis Brussel

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mark La Meir, Phd, MD

Organizational Affiliation

Universitair Ziekenhuis Brussel

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ashley Welch, MD

Organizational Affiliation

Universitair Ziekenhuis Brussel

Official's Role

Study Chair

Facility Information:

Facility Name

universitair Ziekenhuis Brussel

City

Jette

State/Province

Vlaams Brabant

ZIP/Postal Code

1090

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Veerle Van Mossevelde

Phone

+3224763134

veerle.vanmossevelde@uzbrussel.be

12. IPD Sharing Statement

Learn more about this trial

Psychological Well-being of Patients Awaiting for Cardiac Surgery During the COVID-19 Pandemic

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