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Trial record 3 of 90 for:    Cardiac Surgery | United Kingdom
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Patient Recovery From Heart Surgery During the Covid-19 Pandemic (CardiacCovid)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366167
Recruitment Status : Completed
First Posted : April 28, 2020
Last Update Posted : October 13, 2022
Sponsor:
Collaborator:
Queen Mary University of London
Information provided by (Responsible Party):
Barts & The London NHS Trust

Study Description
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Brief Summary:
This study will describe and explore the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will include mortality, morbidity, health-related quality of life, event-specific distress and depression.

Condition or disease Intervention/treatment
Cardiac Surgery COVID Other: Cardiac surgery

Detailed Description:

The overall aim of this study is to describe and explore the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will include mortality, morbidity, health-related quality of life, event-specific distress and depression.

All adult patients having cardiac surgery during the pandemic at St Bartholomew's Hospital will be approached to join this study. As of the end of March this is this is approximately 20 operations a week. Questionnaires will be administered at five time points alongside a review of clinical notes.

Appropriate descriptive and summative statistics will be used to analyse outcomes. If sample size is adequate, possible associations/effect of the impact of the covid-19 pandemic on each of the recovery parameters included in the study will be determined. The differences in outcomes between those with and without covid-19 may also be analysed if the sample size is adequate. Bias and loss to follow-up in observational cohort studies has been considered.

Study Design
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Study Type : Observational
Actual Enrollment : 253 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Cohort Study to Explore Patient Outcome From Heart Surgery During the Covid-19 Pandemic (CardiacCovid)
Actual Study Start Date : April 18, 2020
Actual Primary Completion Date : March 3, 2022
Actual Study Completion Date : March 3, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cardiac surgery patients - lockdown 1
Cohort 1 (lockdown 1): Patients undergoing adult cardiac surgery during the Covid-19 pandemic
 Other: Cardiac surgery
Cardiac surgery during the COVID-19 pandemic
Cardiac surgery patients - lockdown 2
Cohort 2 (lockdown 2): Patients undergoing adult cardiac surgery during the Covid-19 pandemic
 Other: Cardiac surgery
Cardiac surgery during the COVID-19 pandemic
Cardiac surgery patients - lockdown 3
Cohort 3 (lockdown 3): Patients undergoing adult cardiac surgery during the Covid-19 pandemic
 Other: Cardiac surgery
Cardiac surgery during the COVID-19 pandemic


Outcome Measures
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Primary Outcome Measures :
  1. Change in Impact of Events scores [ Time Frame: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery ]
    The revised Impact of Events revised version (IES-R) questionnaire (Weiss and Marmar, 1997) is widely used as a measure of event-specific distress and measures distress experienced by serious life changes/events. It has been commonly used to assess persons with posttraumatic stress disorder (PTSD). It is an 22 item self-report scale where is item is reported on a five point likert scale from 0 (not at all) to 4 (extremely) with respect to how distressing each item has been during the past week. Scale scores are formed for the three subscales, which reflect intrusion (8 items: 1, 2, 3, 6, 9, 14, 16, 20), avoidance (8 items: 5,7,8,11,12,13,17,22), and hyperarousal (6 items: 4,10,15.18.19.21). A cut-off of 26 and above has been suggested for a clinically significant reaction to a psychological trauma, although the IES alone does not diagnose PTSD or reflect a person's ability to function. Metric for summarising data: t-test


Secondary Outcome Measures :
  1. Survival [ Time Frame: Up to 1 year post surgery ]
    Death or survival after cardiac surgery

  2. Morbidity [ Time Frame: Up to 1 year post surgery ]
    patient completion of a log sheet documenting all 'visits' (including calls to NHS 111, face-to-face or virtual visits) to the emergency department, hospital admissions and visits to the general practitioner on a standardised proforma for the duration of the study

  3. Change in Health-related quality of life scores [ Time Frame: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery ]
    Health-related quality of life will be measured using the EQ5D-5L questionnaire. The EQ5D is a standardised, simple generic measure of health well, which is received by patients (Kim et al., 2005). It consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each with five levels of health response and a visual analogue scale (VAS) ranging from 0-100 (0 being the worst possible health imaginable and 100 being the best possible health imaginable). Metric for summarising data: t-test

  4. Change in Depression scores [ Time Frame: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery ]
    Depression will be measured using the Centre for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a 20-item self-report adult instrument designed to measure common symptoms of depression that have occurred over the past week, such as poor appetite, hopelessness, pessimism, and fatigue. All questions are answered on a scale of 0-3, with 0 indicating no symptom presence and with 3 representing symptoms "most or all of the time." CES-D scores range from 0 to 60 with higher scores indicating more severe depressive symptoms. A score of 16 or higher identifies subjects with clinically meaningful depression. Metric for summarising data: t-test


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing cardiac surgery during the COVID-19 pandemic
Criteria

Inclusion Criteria:

  • Undergoing cardiac surgery during the Covid-19 pandemic (end date as yet unknown but inferred when elective surgery is reinstated)
  • Discharge from hospital where operation was performed is being planned
  • Able and willing to give informed consent

Exclusion Criteria:

  • Unable or unwilling to give written informed consent. This includes patients who are being transferred to another hospital and are considered too vulnerable or unwell to be approached (based on clinical judgement of the clinical care team)
  • Unable or unwilling to give and/or complete the questionnaires
  • Inability to understand written and/or verbal English
Contacts and Locations
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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): NCT04366167


Locations
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United Kingdom
St Bartholomew's Hospital
London, United Kingdom, EC1A 7DN
Sponsors and Collaborators
Barts & The London NHS Trust
Queen Mary University of London
Investigators
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Principal Investigator: Julie Sanders, PhD St. Bartholomew's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT04366167    
Other Study ID Numbers: 132127
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: October 13, 2022
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barts & The London NHS Trust:
cardiac surgery
patient reported outcomes
COVID
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases