Quality of Life 12 Months After Cardiac Surgery

NCT05220111 | Completed

• 1 other identifier: R12265
• Study Type: observational
• Target: 1,594
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Quality of Life

Keywords

Quality of Life, postoperative

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Overall mortality rate

  over the follow-up period ranging 3 to 9 years postoperatively

• Overall surgical morbidity rate

  0 to 12 months after surgery

Other Outcomes (1)

• Re-hospitalization rate

  over the follow-up period ranging 3 to 9 years postoperatively

Interventions

Cardiac surgical operation (valve, aorta, coronary arteries) PROCEDURE

Quality of life assessment using EQ-5D-3L

Also known as: Quality of life assessment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator

Study Officials

• Jari Laurikka, MD,PhD

  Head of Department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 2, 2022
• Study Start: April 1, 2013
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2021
• Last Updated: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share