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

NCT ID: NCT02341157

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-03-31

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.

Conditions

COPD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

nSpire Health, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rodney J Folz, MD, PhD

Role: STUDY_DIRECTOR

University of Louisville

Hiram Rivas-Perez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Other Identifiers

NSH 002-00

Identifier Type: -

Identifier Source: org_study_id