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

NCT02341157 | Withdrawn

• 1 other identifier: NSH 002-00
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• : patient diary compliance at 30 and 365 days post-discharge.

  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 Outcomes (3)

• 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.

  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.

  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.

  30 and 365 days

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Have a diagnosis of COPD at or prior to hospitalization.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead
• nSpire Health, Inc.: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodney J Folz, MD, PhD

  University of Louisville

  STUDY DIRECTOR

• Hiram Rivas-Perez, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: January 19, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 11, 2017

Record last verified: 2015-01