- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01182571
Exploration of Fatigue, Uncertainty, Depression and Quality of Life in Heart Transplantation Recipients
August 27, 2010 updated by: National Taiwan University Hospital
Exploration of Fatigue ,Uncertainty ,Depression and Quality of Life in Heart Transplantation Recipients
The purpose of this study is to explore the fatigue, uncertainty, depression and quality of life in heart transplant recipients, and associated factors of quality of life .
Study Overview
Status
Completed
Conditions
Detailed Description
The purpose of this study is to explore the symptom distress, fatigue, depression, uncertainty, and quality of life in heart transplant recipients, and associated factors of quality of life (QOL).
The eligible patients are (1)who undergone heart transplantation were recruited from the Department of Cardiac Surgery, Nation Taiwan University Hospital,(2)18 year old or older.
A set of questionnaire with the Transplant Symptom Frequency and Symptom Distress Scale, Hospital Anxiety and Depression Scale (HADS) , Fatigue Symptom Inventory (FSI), Mishel's Uncertainty Scale, and 12-item Short-Form Health Survey (SF-12) were used to collected symptom distress, fatigue, depression, uncertainty, and QOL .
Study Type
Observational
Enrollment (Actual)
127
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 10051
- National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The outpatients who undergone heart transplantation were recruited from the Department of Cardiac Surgery
Description
Inclusion Criteria:
- Clinical diagnosis of heart transplantation
- Adults 18 years of age
Exclusion Criteria:
- The woman who are pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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heart transplantation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The SF12 Health survey
Time Frame: 1 month
|
It was used to measure quality of life
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1 month
|
|
Transplant Symptom Frequency and Symptom Distress Scale
Time Frame: 1 week
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it was used to measure symptom distress.
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1 week
|
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Fatigue Symptom Inventory
Time Frame: 1 week
|
It was used to measure level of fatigue.
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1 week
|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 1month
|
It was used to measure level of anxiety and depression.
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1month
|
|
Illness Uncertainty Scale
Time Frame: 1 month
|
It was used to measure level of uncertainty.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
August 24, 2009
First Submitted That Met QC Criteria
August 16, 2010
First Posted (Estimate)
August 17, 2010
Study Record Updates
Last Update Posted (Estimate)
August 30, 2010
Last Update Submitted That Met QC Criteria
August 27, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200808050R
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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