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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01182571
First received: August 24, 2009
Last updated: August 27, 2010
Last verified: August 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The SF12 Health survey [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    It was used to measure quality of life

  • Transplant Symptom Frequency and Symptom Distress Scale [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    it was used to measure symptom distress.

  • Fatigue Symptom Inventory [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    It was used to measure level of fatigue.

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1month ] [ Designated as safety issue: No ]
    It was used to measure level of anxiety and depression.

  • Illness Uncertainty Scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 24, 2009
Last Updated: August 27, 2010
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Fatigue
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013