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

Heart Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182571
• Other study ID #: 200808050R
• Status: Completed
• Phase: N/A
• First received: August 24, 2009
• Last updated: August 27, 2010
• Start date: October 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of heart transplantation

• Adults 18 years of age

Exclusion Criteria:

• The woman who are pregnant

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Heart Transplantation

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The SF12 Health survey	It was used to measure quality of life	1 month	No
Primary	Transplant Symptom Frequency and Symptom Distress Scale	it was used to measure symptom distress.	1 week	No
Primary	Fatigue Symptom Inventory	It was used to measure level of fatigue.	1 week	No
Primary	Hospital Anxiety and Depression Scale (HADS)	It was used to measure level of anxiety and depression.	1month	No
Primary	Illness Uncertainty Scale	It was used to measure level of uncertainty.	1 month	No