NCT02212509

Brief Summary

The aims of the cohort study is to describe the rates of 30-day surgical complication, functional decline, frailty and one-year mortality for patients experienced cardiac surgery and to delineate the trajectory of functional capacity 1 year after surgery for the patients. It also will test whether the trajectory of functional varied significantly according to delirium status and its type over the follow-up period and examine the patients' postsurgical actual caloric/protein/fluid intake in relation to the functional capacity within 3 months after surgery as well as evaluate whether activity levels, dietary diversity, and depressive symptoms at 3,6, and 12 months affect patient outcome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 8, 2014

Status Verified

August 1, 2014

Enrollment Period

4.9 years

First QC Date

August 6, 2014

Last Update Submit

August 6, 2014

Conditions

Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • physical activity function

    admission and 1 year after surgery

Secondary Outcomes (1)

  • mortality

    1 year after surgery

Other Outcomes (1)

  • 30 days surgical complication

    30 days after surgery

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients on the cardio-surgical wards

You may qualify if:

  • patients over 20 years old
  • admitted for elective or non-elective cardiac surgery

You may not qualify if:

  • incapable of verbal communication
  • sensory impairment
  • intubation or respiratory isolation
  • patients with critical condition or coma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 8, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 8, 2014

Record last verified: 2014-08

Locations

TW(1)