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Exploration of Fatigue, Uncertainty, Depression and Quality of Life in Heart Transplantation Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01182571
First Posted: August 17, 2010
Last Update Posted: August 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
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 .

Condition
Heart Transplantation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Exploration of Fatigue ,Uncertainty ,Depression and Quality of Life in Heart Transplantation Recipients

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The SF12 Health survey [ Time Frame: 1 month ]
    It was used to measure quality of life

  • Transplant Symptom Frequency and Symptom Distress Scale [ Time Frame: 1 week ]
    it was used to measure symptom distress.

  • Fatigue Symptom Inventory [ Time Frame: 1 week ]
    It was used to measure level of fatigue.

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1month ]
    It was used to measure level of anxiety and depression.

  • Illness Uncertainty Scale [ Time Frame: 1 month ]
    It was used to measure level of uncertainty.


Enrollment: 127
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
heart transplantation

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 .
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The outpatients who undergone heart transplantation were recruited from the Department of Cardiac Surgery
Criteria

Inclusion Criteria:

  • Clinical diagnosis of heart transplantation
  • Adults 18 years of age

Exclusion Criteria:

  • The woman who are pregnant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182571


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10051
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shiow-Ching Shun, PhD National Taiwan University
  More Information

Responsible Party: Shun,Shiow-Ching, Department of Nursing, College of Medicine, National Taiwan University
ClinicalTrials.gov Identifier: NCT01182571     History of Changes
Other Study ID Numbers: 200808050R
First Submitted: August 24, 2009
First Posted: August 17, 2010
Last Update Posted: August 30, 2010
Last Verified: August 2010

Keywords provided by National Taiwan University Hospital:
Heart Transplantation
Symptom Distress
Fatigue
Depression
Quality Of Life.

Additional relevant MeSH terms:
Depression
Fatigue
Behavioral Symptoms
Signs and Symptoms