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Quality of Life After Cardiac Surgery (QUACS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04231461
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : October 4, 2022
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

Study Description
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Brief Summary:
During the last twenty years heart surgery has become safer and the number of patients having heart surgery has increased with more frail patients being offered increasingly complex surgery. Heart operations often improve survival and quality of life (QoL), but that is not true for all patients. Regarding survival, clinicians can measure the risk to life from having a heart operation and the risk to life from not quite precisely, but clinicians have little idea about the impact of heart operations on QoL, which is the outcome that patients care about most. Clinicians are unable to provide patients with robust information on how an operation will affect their QoL. This study will provide this information by analysing the data from patient questionnaires immediately before and after the procedure and monthly thereafter for 12 months.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Mitral Valve Disease Tricuspid Valve Disease Aorta Disease Coronary Artery Bypass Graft Procedure: Cardiac Surgery

Detailed Description:

The Sponsor shall use existing questionnaires to measure QoL in patients having major heart surgery. QoL will be measured before the operation and monthly afterwards for 12 months in order to answer the following questions:

  1. How does having heart surgery affect the QoL immediately after the operation?
  2. How long does it take patients to return to the same quality of life they had before the surgery?
  3. How long does it take patients to regain any loss of quality of life due to the operation? Does quality of life improve thereafter?
  4. What proportion of patients will achieve a net benefit in QoL?
  5. Are there features that can predict who will benefit in terms of QoL and who will not? The Sponsor will use the data to develop an electronic calculator to enable quick and robust evaluation of the impact of heart surgery on the QoL of individuals. Patients will then be able to give truly informed consent and to decide if they wish have surgery based on a full knowledge of both surgical risk and the potential impact on QoL.
Study Design
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Study Type : Observational
Estimated Enrollment : 8004 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life After Cardiac Surgery
Actual Study Start Date : July 19, 2019
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Groups and Cohorts
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Intervention Details:
  • Procedure: Cardiac Surgery
    Routine or urgent cardiac surgery
    Other Names:
    • Aortic Valve Procedure
    • Mitral Valve Procedure
    • Tricuspid Valve Procedure
    • Procedure on Aorta
    • Other major cardiac intervention
    • Other minimal access incisions

Outcome Measures
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Primary Outcome Measures :
  1. Change in Quality of Life using Questionnaire EQ-5D [ Time Frame: 12 Months ]
    Conduct questionnaire EQ-5D to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure.


Secondary Outcome Measures :
  1. Change in Quality of Life using Questionnaire SF-12 [ Time Frame: 12 Months ]
    Conduct questionnaire SF-12 to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure.


Other Outcome Measures:
  1. Change in Quality of Life using Questionnaire LOT [ Time Frame: 12 months ]
    Conduct questionnaire LOT to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure.

  2. Change in Quality of Life using Questionnaire PANAS [ Time Frame: 12 months ]
    Conduct questionnaire PANAS to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure.


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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adults able to understand the patient information sheet written in English.
Criteria

Inclusion Criteria:

  • EuroSCORE II ≥ 3% or EuroSCORE logistic of ≥ 6%
  • Patients undergoing routine/ urgent cardiac surgery
  • Patients must have the ability to provide informed consent

Exclusion Criteria:

  • Patients undergoing salvage or emergency operations
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): NCT04231461


Contacts
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Contact: Christine Mills 01223 639710 christine.mills@nhs.net
Contact: Phil Noyes 01223 639159 p.noyes@nhs.net

Locations
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United Kingdom
Royal Papworth Hospital Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
Contact: Jamie Pack    01223 639623    Jamie.Pack@nhs.net   
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Investigators
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Study Director: Samer Nashef Chief Investigator Royal Papworth Hospital
More Information
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Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04231461    
Other Study ID Numbers: P02500
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: October 4, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant data is not to be shared with researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction