Evaluation of COPD Co-Pilot

NCT03018847 | Unknown

• 1 other identifier: CPV2-2016-S1
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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. .

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Patient Adoption

  Percentage of potential daily symptom reports completed by patients

  6 months

Secondary Outcomes (16)

• Patient Satisfaction

  6 months

• Inpatient Admissions

  6 months

• Emergency department visits

  6 months

• Clinic visits

  6 months

• Patient reported respiratory symptoms

  6 months

Interventions

COPD Co-Pilot DEVICE

The COPD Co-Pilot is a system that guides a patient through a software application (web or mobile app) to collect, track, and trend daily symptoms related to Chronic Obstructive Pulmonary Disease (COPD). The system is intended to be used by patients as a support tool to track COPD symptoms as part of their personal disease management plan. The COPD Co-Pilot allows health care providers to view and triage subject symptoms via the provider web-based application. Health care providers also have the ability to send responses to subjects, like medication recommendations, through preset forms in the system.

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Subject has a cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage
• Subject is currently known to suffer from or have a history of significant substance abuse within the last 2 years
• Subject has any condition that in the opinion of the provider may adversely affect their participation
• Subject is residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
• 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
• Subject has no cellular coverage at their primary residence
• Subject plans to travel to a location with no cellular coverage for a significant period (\>1 week) during their program participation

Sponsors & Collaborators

• HGE Health Care Solutions, LLC: lead
• PneumRx, Inc.: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (5)

• 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.

  PMID: 26451903 BACKGROUND

• 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.

  PMID: 26259074 BACKGROUND

• 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.

  PMID: 21495839 BACKGROUND

• 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.

  PMID: 28848862 BACKGROUND

• Remakus, Christopher B., et al.

  BACKGROUND

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

• Tatsiana Beiko, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 12, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)