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COPDNCT03018847

Evaluation of COPD Co-Pilot

An observational study of COPD, run by HGE Health Care Solutions, LLC at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
COPD
What is being tested?
COPD Co-Pilot
Type of treatment
Medical device
How many people
23 participants
Where
1 siteUnited States
Study dates
Jan 2017to Mar 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

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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Conditions
COPD
Being tested
COPD Co-Pilot
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COPD Co-PilotDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Adoption

    Percentage of potential daily symptom reports completed by patients

    Measured: 6 months

Secondary outcomes (16)

  1. Patient Satisfaction

    patient satisfaction questionnaire

    Measured: 6 months

  2. Inpatient Admissions

    admission records for period prior to study and during study

    Measured: 6 months

  3. Emergency department visits

    emergency department records for period prior to study and during study

    Measured: 6 months

  4. Clinic visits

    clinic visits for period prior to study and during study

    Measured: 6 months

  5. 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.

    Measured: 6 months

  6. 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.

    Measured: 6 months

  7. 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.

    Measured: 6 months

  8. 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.

    Measured: 6 months

  9. 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.

    Measured: 6 months

  10. Medications

    list of medications entered by site coordinator, provider, or reported by subjects to Health Assistants during scheduled monthly phone calls.

    Measured: 6 months

  11. Patient profile information

    This will include, among other variables, medial history, smoking history, spirometry results, oxygen use, and diagnoses of co-morbidities.

    Measured: 6 months

  12. Medication compliance

    compliance with newly prescribed treatments as reported by patients during follow up phone calls.

    Measured: 6 months

  13. 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

    Measured: 6 months

  14. 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.

    Measured: 6 months

  15. 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.

    Measured: 6 months

  16. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completionMar 2018 (estimated)
  4. Study completionMar 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03018847
Sponsor's protocol ID
CPV2-2016-S1
Status last verified
Mar 2018
First submitted
10 Jan 2017
Last updated
13 Mar 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 26451903

  • 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.

    PubMed 26259074

  • 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.

    PubMed 21495839

  • 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.

    PubMed 28848862

  • Remakus, Christopher B., et al.

Questions about this trial

What is this clinical trial studying?

An observational study of COPD, run by HGE Health Care Solutions, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Adoption (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03018847, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.

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