NCT01182571

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
12 months until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
Last Updated

August 30, 2010

Status Verified

August 1, 2010

Enrollment Period

10 months

First QC Date

August 24, 2009

Last Update Submit

August 27, 2010

Conditions

Heart Transplantation

Keywords

Heart TransplantationSymptom DistressFatigueDepressionQuality Of Life.

Outcome Measures

Primary Outcomes (5)

  • The SF12 Health survey

    It was used to measure quality of life

    1 month

  • Transplant Symptom Frequency and Symptom Distress Scale

    it was used to measure symptom distress.

    1 week

  • Fatigue Symptom Inventory

    It was used to measure level of fatigue.

    1 week

  • Hospital Anxiety and Depression Scale (HADS)

    It was used to measure level of anxiety and depression.

    1month

  • Illness Uncertainty Scale

    It was used to measure level of uncertainty.

    1 month

Study Arms (1)

heart transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The outpatients who undergone heart transplantation were recruited from the Department of Cardiac Surgery

You may qualify if:

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

You may not qualify if:

  • The woman who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10051, Taiwan

Location

MeSH Terms

Conditions

FatigueDepression

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Shiow-Ching Shun, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 17, 2010

Study Start

October 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 30, 2010

Record last verified: 2010-08

Locations

TW(1)