Patient Recovery From Heart Surgery During the Covid-19 Pandemic

NCT04366167 | Completed

• 1 other identifier: 132127
• Study Type: observational
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; COVID

Keywords

cardiac surgery; patient reported outcomes; COVID

Outcome Measures

Primary Outcomes (1)

• Change in Impact of Events scores

  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

  Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery

Secondary Outcomes (4)

• Survival

  Up to 1 year post surgery

• Morbidity

  Up to 1 year post surgery

• Change in Health-related quality of life scores

  Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery

• Change in Depression scores

  Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery

Study Arms (3)

Cardiac surgery patients - lockdown 1

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

Other: Cardiac surgery

Cardiac surgery patients - lockdown 2

Cohort 2 (lockdown 2): Patients undergoing adult cardiac surgery during the Covid-19 pandemic

Other: Cardiac surgery

Cardiac surgery patients - lockdown 3

Cohort 3 (lockdown 3): Patients undergoing adult cardiac surgery during the Covid-19 pandemic

Other: Cardiac surgery

Interventions

Cardiac surgery OTHER

Cardiac surgery during the COVID-19 pandemic

Cardiac surgery patients - lockdown 1; Cardiac surgery patients - lockdown 2; Cardiac surgery patients - lockdown 3

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing cardiac surgery during the COVID-19 pandemic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Queen Mary University of London: collaborator

Study Sites (1)

St Bartholomew's Hospital

London, EC1A 7DN, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 37585652 DERIVED

• 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.

  PMID: 36099505 DERIVED

MeSH Terms

Interventions

Cardiac Surgical Procedures

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Julie Sanders, PhD

  St. Bartholomew's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: April 18, 2020
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: October 13, 2022

Record last verified: 2021-10

Locations

GB (1)