Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT02341157
Status:
WITHDRAWN
Last Update Posted:
2017-04-11
First Post:
2014-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICE COPD PikoLogic® Cohort Study.Implementation, Compliance, and Effectiveness of Integrating the PikoLogic®
Sponsor:
University of Louisville
Organization:
Study Overview
Official Title:
Implementation, Compliance, and Effectiveness of Integrating the PikoLogic® Into Disease Management Discharge Care for Patients With COPD Exacerbation: A Prospective Cohort Study.
Status:
WITHDRAWN
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator left the University of Louisville.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICE
Brief Summary:
This is a two-step observational cohort study evaluating the impact of adding PikoLogic® to the current disease management COPD discharge protocol subsequent to an admission for COPD exacerbation.
Detailed Description:
Candidate subjects participating in the cohort study will receive training by the clinical research associate (CRA) on the use of PikoLogic® for home disease management prior to discharge from the hospital. The CRA will also confirm COPD discharge education was completed by a discharge coordinator and the patient understood the instructions. The CRA will review "seek medical care if:" and "seek immediate medical care if:" instructions at discharge. The discharge CRA will also evaluate subjects for their ability to use the PikoLogic® correctly and will score the patient using an objective and subjective measurement tool. A modified Discharge Knowledge Assessment Tool© will be utilized.1 Objective measurements will include training time and patient compliance with PikoLogic® prior to discharge. Subjective data scores and objective measurements will be utilized for program implementation evaluation.
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?: