Technology Dependency and Health-Related Quality of Life

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. Identifier: NCT00022984
Recruitment Status : Completed
First Posted : August 20, 2001
Last Update Posted : March 4, 2008
Information provided by:
National Institutes of Health Clinical Center (CC)

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.

Condition or disease
Cardiovascular Disease

Detailed Description:
With the efficacy of implantable cardioverter defibrillator (ICD ) therapy well established, the survival time of recipients of this technology must be interpreted more broadly. It is important to better understand how ICD recipients perceive their dependence on this life saving technology and how these perceptions influence their Health Related Quality of Life (HRQL). The purpose of this cross sectional, predictive study is to test a causal model that may explain the link between attitudes towards dependency on technology and HRQL in a sample of adult ICD recipients. The hypothesized model consists of seven variables: attitudes towards technology dependency; age; gender; illness history; illness representation; symptom distress; and HRQL. Adult subjects (greater than 18 years) who have received an ICD will be asked to participate. Subjects will complete a self-administered, mailed questionnaire that includes five instruments: 1) The Medical Outcomes Short Form 36 Survey Version 1.0; 2) The Important Concerns and Distress Questionnaire; 3) The Illness Perception Questionnaire; 4) The Dependency on Technology Scales; 5) Demographic Questionnaire. The model will be tested statistically by use of Structural Equation Modeling techniques. The definitive goal of this study is to develop a theoretically meaningful and statistically well-fitting model that specifies how dependence on technology influences HRQL. The hypothesis for this study is that the full structural equation model fits data from the sample of adult ICD recipients.

Study Type : Observational
Enrollment : 125 participants
Official Title: Toward a Theory of Technology Dependency and Health Related Quality of Life (HRQL): A Test of a Model in Patients With an Implantable Cardioverter Defibrillator
Study Start Date : August 2001
Study Completion Date : August 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Male or female adults (18 years of age or older).

Implantable cardioverter defibrillator.


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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 identifier (NCT number): NCT00022984

United States, Maryland
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC) Identifier: NCT00022984     History of Changes
Other Study ID Numbers: 010237
First Posted: August 20, 2001    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: August 2004

Keywords provided by National Institutes of Health Clinical Center (CC):
Attitudes Towards Technology
Cardiovascular Disease
Illness Representation
Implantable Cardioverter Defibrillator
Symptom Distress
Heart Disease

Additional relevant MeSH terms:
Cardiovascular Diseases