Technology Dependency and Health-Related Quality of Life

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00022984
First received: August 17, 2001
Last updated: March 3, 2008
Last verified: August 2004
  Purpose

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
Cardiovascular Disease

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 125
Study Start Date: August 2001
Estimated Study Completion Date: August 2004
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

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

Implantable cardioverter defibrillator.

EXCLUSION CRITERIA:

Unable to read written English.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022984

Locations
United States, Maryland
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00022984     History of Changes
Other Study ID Numbers: 010237, 01-CC-0237
Study First Received: August 17, 2001
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014