- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02341157
ICE COPD PikoLogic® Cohort Study.Implementation, Compliance, and Effectiveness of Integrating the PikoLogic® (ICE)
April 7, 2017 updated by: University of Louisville
Implementation, Compliance, and Effectiveness of Integrating the PikoLogic® Into Disease Management Discharge Care for Patients With COPD Exacerbation: A Prospective Cohort Study.
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.
Study Overview
Status
Withdrawn
Conditions
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 Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Have a diagnosis of COPD at or prior to hospitalization.
Description
Inclusion Criteria:
- Have a diagnosis of COPD at or prior to hospitalization.
Be hospitalized for one of the following reasons:
- COPD exacerbation
- COPD
- COPD with pneumonia
- Be an ex-smoker or current smoker with a smoking history of ≥ 10 pack years (i.e., 1 pack [20 cigarettes] per day for 10 years).
- Be judged by the investigator to be in stable health (except for COPD variability) on the basis of medical history, physical examination, and routine laboratory data, and appears able to successfully complete this study.
- Be willing to perform daily objective and subjective measurements using the PikoLogic® device and maintain daily utilization for 1 year following discharge.
- The subject is fluent in English for reading and writing.
- The subject provides written informed consent for the trial.
Exclusion Criteria:
- Has a current diagnosis of any disease with chronic airflow obstruction other than COPD.
- Is unwilling to use the PikoLogic® and unwilling to maintain a written record of hospitalization for 1 year.
- Lives in a neighborhood with poor or no cellular coverage.
- Is currently homeless or in jeopardy of being homeless during the 1 year study period.
- Does not have a means to be transported to the follow up study visits.
- Cannot be contacted easily.
- Discharges against medical advice.
- In hospice within one year prior to admission.
- Is associated with the administration of the study. No family member of the investigational study staff may participate in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
: patient diary compliance at 30 and 365 days post-discharge.
Time Frame: 30 days and 365 day reviews
|
To evaluate short term clinical implementation and patient compliance of a COPD PikoLogic® discharge action plan for COPD patients to assist in home care self-monitoring.
|
30 days and 365 day reviews
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to first severe exacerbation, as defined by an event requiring hospitalization or evaluation in the emergency department 30 days to 1 year after enrollment.
Time Frame: 30 Days
|
30 Days
|
Number of severe exacerbations, as defined by an event requiring hospitalization or evaluation in the emergency department 30 days to 1 year after enrollment.
Time Frame: 30 and 365 Days
|
30 and 365 Days
|
Cost of care, defined as patient healthcare resource utilization and hospital charges if readmission occurs, in the 1 year (52 weeks) following 30 days from hospital discharge for treatment of COPD exacerbation.
Time Frame: 30 and 365 days
|
30 and 365 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Rodney J Folz, MD, PhD, University of Louisville
- Principal Investigator: Hiram Rivas-Perez, MD, University of Louisville
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
March 1, 2017
Study Registration Dates
First Submitted
December 18, 2014
First Submitted That Met QC Criteria
January 13, 2015
First Posted (Estimate)
January 19, 2015
Study Record Updates
Last Update Posted (Actual)
April 11, 2017
Last Update Submitted That Met QC Criteria
April 7, 2017
Last Verified
January 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- NSH 002-00
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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