Evaluation of COPD Co-Pilot

The purpose of undertaking this study is to examine the use of COPD Co-PilotTM, a COPD disease management program manufactured and operated by HGE Health Care Solutions, LLC, in COPD patients outside of the geographic base of HGE's existing patient population (Philadelphia, PA). The purpose is to demonstrate the feasibility of expanding the program to additional geographic sites and to examine whether similar outcome measures are achieved in patients under the supervision of health care providers that are new to the program.

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Study Overview

• Status: Unknown
• Conditions: COPD
• Intervention / Treatment: Device: COPD Co-Pilot

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects shall be recruited from the pool of patients at the investigative site that have been diagnosed with moderate to severe COPD.

The study is planned to enroll 100 subjects. The study will be conducted at one investigative site in the United States, the Medical University of South Carolina Health System. Recruitment will stop when 100 subjects are enrolled. There will be no replacement for dropouts. Recruitment is planned to last approximately 6 months.

Description

Inclusion Criteria:

1. Subject has read, understood and signed an informed consent form prior to enrollment.
2. Males or females age ≥35 years old
3. Documented diagnosis of moderate to very severe COPD (GOLD Level II-IV)
4. Must be able to read and understand English and consent for themselves
5. Subject is willing and able to use an iPad mini device.

Exclusion Criteria:

1. Subject has a cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage
2. Subject is currently known to suffer from or have a history of significant substance abuse within the last 2 years
3. Subject has any condition that in the opinion of the provider may adversely affect their participation
4. Subject is residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
5. Subject has a planned procedures at time of enrollment that will occur within timeframe of study that will require hospitalization or otherwise adversely affect their ability to participate
6. Subject has no cellular coverage at their primary residence
7. Subject plans to travel to a location with no cellular coverage for a significant period (>1 week) during their program participation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Adoption	Percentage of potential daily symptom reports completed by patients	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	patient satisfaction questionnaire	6 months
Inpatient Admissions	admission records for period prior to study and during study	6 months
Emergency department visits	emergency department records for period prior to study and during study	6 months
Clinic visits	clinic visits for period prior to study and during study	6 months
Patient reported respiratory symptoms	Daily values for breathlessness, sputum quantity, sputum color, sputum consistency, peak flow, temperature over 100 F, cough, wheeze, sore throat, and nasal congestion.	6 months
Symptom change detected	Change index (a numeric value) and the categorical level of change that corresponds to the patient's reported symptoms when compared to their baseline. This is recorded for each daily symptom report submitted after completion of the run-in period.	6 months
Hospitalization history	hospitalization history reported to Health Assistants by patients during scheduled monthly phone calls. This will be reconciled with admissions data from the site and may include utilization at other institutions.	6 months
Medication compliance	compliance with newly prescribed treatments as reported by patients during follow up phone calls.	6 months
Episode duration	the date when a mild, moderate or significant level of change is first detected for a patient through the date immediately followed by seven consecutive days in which no level of change is detected. The total number of days in this period, symptoms reported during this period, and clinical responses communicated to the patient (including any treatments or changes) will be reported for analysis.	6 months
Clinical responses	the date, medication or instruction, dosage, frequency, duration of clinical responses sent to subjects, and time elapsed between the patient's check-in and the time the response was acknowledged by the patient.	6 months
Medications	list of medications entered by site coordinator, provider, or reported by subjects to Health Assistants during scheduled monthly phone calls.	6 months
Patient profile information	This will include, among other variables, medial history, smoking history, spirometry results, oxygen use, and diagnoses of co-morbidities.	6 months
Length of stay	total number of inpatient days and the average length of stay per admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient date of birth (DOB), location, length of stay, attending physician, admission diagnosis and diagnosis at discharge. Reported for period prior to study and during study period	6 months
Readmissions	The number of inpatient admissions that occurred within 30, 60, and 90 days of discharge from a prior admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient DOB, location, length of stay, attending physician, admission diagnosis, diagnosis at discharge, and associated costs broken down by category. This will be reported for time prior to study and during study period.	6 months
Readmission rate	The rate and percent of inpatient admissions that occurred within 30, 60, and 90 days of discharge from a prior admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient DOB, location, length of stay, attending physician, admission diagnosis and diagnosis at discharge. These will be reported for the period prior to the start of the study through the study period.	6 months
Source of inpatient admissions and visits to the Emergency Department (ED)	The source (e.g. from home, from accident, from outpatient clinical, at direction of physician, from ED, etc.) of each and every inpatient admission an emergency department visit will be reported for analyses. These will be reported for the period prior to the enrollment through the study period.	6 months

Collaborators and Investigators

• Sponsor: HGE Health Care Solutions, LLC
• Collaborators: PneumRx, Inc.
• Investigators: Principal Investigator: Tatsiana Beiko, MD, Medical University of South Carolina

Publications and helpful links

General Publications

• Smith HS, Criner AJ, Fehrle D, Grabianowski CL, Jacobs MR, Criner GJ. Use of a SmartPhone/Tablet-Based Bidirectional Telemedicine Disease Management Program Facilitates Early Detection and Treatment of COPD Exacerbation Symptoms. Telemed J E Health. 2016 May;22(5):395-9. doi: 10.1089/tmj.2015.0135. Epub 2015 Oct 9.
• Cordova FC, Ciccolella D, Grabianowski C, Gaughan J, Brennan K, Goldstein F, Jacobs MR, Criner GJ. A Telemedicine-Based Intervention Reduces the Frequency and Severity of COPD Exacerbation Symptoms: A Randomized, Controlled Trial. Telemed J E Health. 2016 Feb;22(2):114-122. doi: 10.1089/tmj.2015.0035. Epub 2015 Aug 10.
• Kim V, Garfield JL, Grabianowski CL, Krahnke JS, Gaughan JP, Jacobs MR, Criner GJ. The effect of chronic sputum production on respiratory symptoms in severe COPD. COPD. 2011 Apr;8(2):114-20. doi: 10.3109/15412555.2011.558546.
• So JY, Lastra AC, Zhao H, Marchetti N, Criner GJ. Daily Peak Expiratory Flow Rate and Disease Instability in Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2015 Nov 11;3(1):398-405. doi: 10.15326/jcopdf.3.1.2015.0142.
• Remakus, Christopher B., et al.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 12, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 12, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CPV2-2016-S1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO