Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022984
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-08-17
Brief Title:
Technology Dependency and Health-Related Quality of Life
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2004-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 10 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-CC-0237 | None | None | None |