Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT02026102
Status:
COMPLETED
Last Update Posted:
2019-10-31
First Post:
2013-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)
Status:
COMPLETED
Status Verified Date:
2019-10
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:
The purpose of this study is to test the acceptability and feasibility of a "toolkit" of patient decision aids (PtDAs) for heart failure patients who are considering an ICD implant.
Detailed Description:
Specific Aim 1: Examine acceptability and feasibility of a toolkit of patient decision aids (PtDAs) for patients with heart failure referred for primary prevention implantable cardioverter-defibrillators using a randomized control trial design across three diverse health care systems (Kaiser Colorado, The University of Colorado, and The Denver Veterans Hospital).
1. Measure the acceptability of the decision aids
2. Explore feasibility by measuring patient participation rates and adherence to the study protocol across all three sites.
3. Conduct a preliminary assessment of outcomes by measuring changes in decision quality (knowledge and value concordance), quality of life, depressive symptoms, health status, and spiritual well-being.
Specific Aim 2: Determine the relative value of the various tools in the toolkit through in-depth interviews from study participants and providers at each intervention site
1. Measure the acceptability of the decision aids
2. Explore feasibility by measuring patient participation rates and adherence to the study protocol across all three sites.
3. Conduct a preliminary assessment of outcomes by measuring changes in decision quality (knowledge and value concordance), quality of life, depressive symptoms, health status, and spiritual well-being.
Specific Aim 2: Determine the relative value of the various tools in the toolkit through in-depth interviews from study participants and providers at each intervention site
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 121483 | OTHER_GRANT | Patient Centered Outcomes Research Institute (PCORI) | View |