Quality of Life 12 Months After Cardiac Surgery

Sponsor

Tampere University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05220111

Collaborator

Tampere University (Other)

1,594

Enrollment

105

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Quality of Life	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1594 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Quality of Life 12 Months After Cardiac Surgery

Actual Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Re-hospitalization rate [over the follow-up period ranging 3 to 9 years postoperatively]
Re-admittance to health care facilities, annual postoperative, in percent

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tampere University Hospital
Tampere University

Investigators

Study Director: Jari Laurikka, MD,PhD, Head of Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tampere University Hospital

ClinicalTrials.gov Identifier:

NCT05220111

Other Study ID Numbers:

R12265

First Posted:

Feb 2, 2022

Last Update Posted:

Feb 2, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tampere University Hospital

Quality of Life, postoperative

Study Results

No Results Posted as of Feb 2, 2022