Quality of Life 12 Months After Cardiac Surgery

Cardiac surgical patients entering the hospital for operation were voluntarily recruited to participate a 12 month follow- up of health related quality of life (QOL)

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Procedure: Cardiac surgical operation (valve, aorta, coronary arteries)

Detailed Description

Cardiac surgical patients entering the hospital for operation were voluntarily recruited to participate a 12 month follow- up of health related quality of life based on established QOL measurements with EuroQol quality of life 5 dimensional 3 level (EQ-5D-3L) description system at preoperative, 6 months and 12 months postoperatively. The study started on May 2013 and ended at the end of 2018. The data has been analyzed for publication in 2021. The total number of patients reached 1594.

• Study Type: Observational
• Enrollment (Actual): 1594

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All comers for primary or secondary major cardiac surgery (cabg, valve, aorta or combined procedures)

Description

Inclusion Criteria:

• elective or urgent cardiac surgery (open heart procedure to valves or ascending aorta /arch, on-pump or off-pump surgery to the coronary arteries )
• willingness to participate,
• ability to comprehend Finnish language

Exclusion Criteria:

• emergency surgery (with no time to introduce the study in good time)
• not willing to participate,
• blind or other disturbance in seeing,
• inability to comprehend Finnish language

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-Visual Analogue Scale result, preoperative	EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent	preoperative
EQ-Visual Analogue Scale result, at 6 months	EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent	6 months after surgery
EQ-Visual Analogue Scale result, at 12 months	EQ-Visual Analogue Scale, scale 0 (worst) to 100 (best possible), in percent	12 months after surgery
Results of preoperative Quality of life dimensions	5 dimensions measurable with EQ5D-3L (scale 1,2 or 3) (ordinal scale)	preoperative
Results of Quality of life dimensions at 6 months after surgery	5 dimensions measurable with EQ5D-3L (scale 1,2 or 3)(ordinal scale)	6 months after surgery
Results of Quality of life dimensions at 12 months after surgery	5 dimensions measurable with EQ5D-3L (scale 1,2 or 3)(ordinal scale)	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall mortality rate	Survival after surgery, annual postoperative, in percent	over the follow-up period ranging 3 to 9 years postoperatively
Overall surgical morbidity rate	All surgical and cardiovascular complications, in percent	0 to 12 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-hospitalization rate	Re-admittance to health care facilities, annual postoperative, in percent	over the follow-up period ranging 3 to 9 years postoperatively

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Tampere University
• Investigators: Study Director: Jari Laurikka, MD,PhD, Head of Department

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Quality of Life, postoperative
• Other Study ID Numbers: R12265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: local legislation prevents personal data sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No