Clinical trial NCT04231461: Quality of Life After Cardiac Surgery
Official title: Quality of Life After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Mitral Valve Disease
Tricuspid Valve Disease
Aorta Disease
Coronary Artery Bypass Graft
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2020-01-18
Enrollment: 2925
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults able to understand the patient information sheet written in English.

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Quality of Life using Questionnaire EQ-5D
timeFrame: 12 Months
Secondary outcomes:
measure: Change in Quality of Life using Questionnaire SF-12
timeFrame: 12 Months
Other outcomes:
measure: Change in Quality of Life using Questionnaire LOT
timeFrame: 12 months
measure: Change in Quality of Life using Questionnaire PANAS
timeFrame: 12 months
Locations:
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
state: Cambridgeshire
Study officials:
affiliation: Chief Investigator Royal Papworth Hospital
name: Samer Nashef
role: STUDY_DIRECTOR
References: