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ICE COPD PikoLogic® Cohort Study.Implementation, Compliance, and Effectiveness of Integrating the PikoLogic® | Clinical Trials | Clareo Health

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ICE COPD PikoLogic® Cohort Study.Implementation, Compliance, and Effectiveness of Integrating the PikoLogic®

Implementation, Compliance, and Effectiveness of Integrating the PikoLogic® Into Disease Management Discharge Care for Patients With COPD Exacerbation: A Prospective Cohort Study.

NCT02341157•University of Louisville

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Have a diagnosis of COPD at or prior to hospitalization.
•2. Be hospitalized for one of the following reasons:
•* COPD exacerbation
•* COPD
•* COPD with pneumonia
•3. 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).
•4. 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.
•5. Be willing to perform daily objective and subjective measurements using the PikoLogic® device and maintain daily utilization for 1 year following discharge.
•6. The subject is fluent in English for reading and writing.
•7. The subject provides written informed consent for the trial.

Exclusion Criteria

•1. Has a current diagnosis of any disease with chronic airflow obstruction other than COPD.
•2. Is unwilling to use the PikoLogic® and unwilling to maintain a written record of hospitalization for 1 year.
•3. Lives in a neighborhood with poor or no cellular coverage.
•4. Is currently homeless or in jeopardy of being homeless during the 1 year study period.
•5. Does not have a means to be transported to the follow up study visits.
•6. Cannot be contacted easily.
•7. Discharges against medical advice.
•8. In hospice within one year prior to admission.
•9. Is associated with the administration of the study. No family member of the investigational study staff may participate in this study.

Key Dates

Start Date

January 1, 2015

Primary Completion Date

December 1, 2016

Completion Date

March 1, 2017

Last Updated

April 11, 2017

Conditions

COPD

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

ICE COPD PikoLogic® Cohort Study.Implementation, Compliance, and Effectiveness of Integrating the PikoLogic®

Inclusion Criteria

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