Patient Recovery From Heart Surgery During the Covid-19 Pandemic

NCT ID: NCT04366167

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

253 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-18

Study Completion Date

2022-03-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Surgery COVID

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac surgery patients - lockdown 1

Cohort 1 (lockdown 1): Patients undergoing adult cardiac surgery during the Covid-19 pandemic

Cardiac surgery

Intervention Type OTHER

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

Cardiac surgery

Intervention Type OTHER

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

Cardiac surgery

Intervention Type OTHER

Cardiac surgery during the COVID-19 pandemic

Interventions

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Cardiac surgery

Cardiac surgery during the COVID-19 pandemic

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Mary University of London

OTHER

Sponsor Role collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie Sanders, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Bartholomew's Hospital

Locations

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St Bartholomew's Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Sanders J, Beaumont E, Dodd M, Murray SE, Owens G, Berry A, Hyde E, Bueser T, Clayton T, Oo AY. The impact of the COVID-19 pandemic on recovery from cardiac surgery over time: results of the CardiacCovid study from three UK national lockdowns. Eur J Cardiovasc Nurs. 2024 May 28;23(4):418-422. doi: 10.1093/eurjcn/zvad084.

Reference Type DERIVED
PMID: 37585652 (View on PubMed)

Sanders J, Bueser T, Beaumont E, Dodd M, Murray SE, Owens G, Berry A, Hyde E, Clayton T, Oo AY. The impact of the COVID-19 pandemic on recovery from cardiac surgery: 1-year outcomes. Eur J Cardiovasc Nurs. 2023 Jul 19;22(5):516-528. doi: 10.1093/eurjcn/zvac083.

Reference Type DERIVED
PMID: 36099505 (View on PubMed)

Other Identifiers

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132127

Identifier Type: -

Identifier Source: org_study_id

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