NCT00022984

Brief Summary

This study will explore how people with an implanted cardioverter defibrillator (ICD) feel that dependence on this life-saving technology affects their health-related quality of life. ICD therapy is an important treatment option for patients with serious recurrent abnormal heart rhythms. Overall survival is significantly improved in high risk patients who receive this therapy. This study will explore patients' perceptions of the impact of this device on their health status and well being, and their physical, psychological and social functioning. Patients 18 years of age or older who have an implanted cardioverter defibrillator may be eligible for this study. Participants will fill out a questionnaire booklet containing 170 questions about how they feel about their health, including their concerns and stresses, feelings about dependency on life-saving technology, and illness perception. There are also questions on demography, such as age, marital status, employment, etc. The booklet may take up to 30 minutes to complete. Information obtained from this study may lead to a better understanding of how people feel about their health after receiving an ICD and help patients and families adapt to living with the device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2001

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2001

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 2004

First QC Date

August 17, 2001

Last Update Submit

March 3, 2008

Conditions

Keywords

Attitudes Towards TechnologyCardiovascular DiseaseIllness RepresentationImplantable Cardioverter DefibrillatorSymptom DistressHeart DiseaseICD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female adults (18 years of age or older).
  • Implantable cardioverter defibrillator.

You may not qualify if:

  • Unable to read written English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 17, 2001

First Posted

August 20, 2001

Study Start

August 1, 2001

Study Completion

August 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-08

Locations