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Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery

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ClinicalTrials.gov Identifier: NCT01127802
Recruitment Status : Unknown
Verified May 2010 by National Taiwan University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : May 21, 2010
Last Update Posted : May 21, 2010
Sponsor:
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date May 20, 2010
First Posted Date May 21, 2010
Last Update Posted Date May 21, 2010
Study Start Date January 2010
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Official Title Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing CABG Surgery
Brief Summary The purpose of this study is to explore the changes of functional status, symptoms distress and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery.
Detailed Description This is an observational cohort study. The participants will be inpatients undergoing elective CABG surgery at one tertiary medical center. Functional status (including activity of daily living, cognitive and nutritional status), symptom distress, and quality of life will be measured at multiple points: pre-surgery, day 1 to 7 post-surgery, before discharge, and 2-4 weeks after discharge. Structured questionnaire will be used to collect demographic and medical characteristics. The Barthel Index, hand-held dynamometer, 6-minute walking test, Mini-Nutritional Assessment (MNA), Mini-Mental State Examination (MMSE), Confusion Assessment Method (CAM), Symptoms Distress Scale, and Short-Form-36 Health Survey (SF-36) will be used to collect functional data and compared for changes. The trajectory of functional status, symptoms distress, and quality of life will be further analyzed. The findings will add to the literature by raising the awareness on changes of functional status, symptoms distress, and quality of life for patients undergoing elective CABG so targeted and timely intervention could be developed and planned.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients undergoing elective CABG surgery
Condition Coronary Artery Bypass Graft Surgery
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 20, 2010)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2011
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • receive elective coronary artery bypass surgery
  • able to communicate in Chinese and Taiwanese
  • walk independently or use walker
  • length of stay is over 7 days

Exclusion Criteria:

  • unable to walk
  • mechanical ventilation
  • neural or muscle disease to influence ambulation(ex: Parkinson Disease)
  • asthma
  • severe psychotic disorder that prevents patient from participating in test
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01127802
Other Study ID Numbers 201003017R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cheryl Chia-Hui Chen, Department of Nursing, College of Medicine, National Taiwan University
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Study Chair: Chia-Hui Chen, Ph. D. National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date May 2010