NCT04406181

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:

  1. 1.The degree of anxiety and/or depression induced by their altered medical care trajectory.
  2. 2.The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit
  3. 3.The occurrence of reduced access to medical and psychological help

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

May 18, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

April 28, 2020

Last Update Submit

May 28, 2020

Conditions

Anxiety and FearAnxiety DepressionAnxiety PostoperativePsychological Stress

Keywords

cardiac surgerypostoperative consultationpostponed elective surgeryCOVID-19

Outcome Measures

Primary Outcomes (3)

  • 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)

    10 minutes

  • 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.

    10 minutes

  • Reduced access to medical and psychological help

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

    10 minutes

Study Arms (3)

operation deferred

OTHER

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

Behavioral: HADSBehavioral: a survey

no operation date

OTHER

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

Behavioral: HADSBehavioral: a survey

postoperative consultation deferred

OTHER

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

Behavioral: HADSBehavioral: a survey

Interventions

HADSBEHAVIORAL

Hospital Anxiety and Depression Scale

Also known as: questionnaire
no operation dateoperation deferredpostoperative consultation deferred
a surveyBEHAVIORAL

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

no operation dateoperation deferredpostoperative consultation deferred

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersStress, PsychologicalCOVID-19

Interventions

4-amino-4'-hydroxylaminodiphenylsulfoneSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jan Nijs, MD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

  • Mark La Meir, Phd, MD

    Universitair Ziekenhuis Brussel

    STUDY DIRECTOR

  • Ashley Welch, MD

    Universitair Ziekenhuis Brussel

    STUDY CHAIR

Central Study Contacts

Veerle Van Mossevelde, Data Nurse

CONTACT

+3224763134veerle.vanmossevelde@uzbrussel.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Data Nurse

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 28, 2020

Study Start

May 18, 2020

Primary Completion

December 31, 2020

Study Completion

January 1, 2021

Last Updated

June 1, 2020

Record last verified: 2020-05

Locations

BE(1)