Coronary Artery Bypass Graft SurgeryNCT01127802
Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
An observational study of Coronary Artery Bypass Graft Surgery, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing elective CABG surgery
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing CABG Surgery
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.
Read the 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.
- Conditions
- Coronary Artery Bypass Graft Surgery
- Keywords
- CABG, functional status, symptoms distress, quality of life, the trajectory of functional status, the changes of symptoms distress, the changes of quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chia-Hui Chen, Ph. D., Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127802
- Sponsor's protocol ID
- 201003017R
- Status last verified
- May 2010
- First submitted
- 20 May 2010
- Last updated
- 21 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing CABG Surgery
- ClinicalTrials.gov ID
- NCT01127802
- Acronym / sponsor ID
- 201003017R
- Conditions
- Coronary Artery Bypass Graft Surgery
- Keywords
- CABG, functional status, symptoms distress, quality of life, the trajectory of functional status, the changes of symptoms distress, the changes of quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 21 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing elective CABG surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Hui Chen, Ph. D. study chair
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass Graft Surgery, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2010.