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Assessing Adherence to Home Telemedicine in Individuals With Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369885
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
Midmark Corporation
Monitored Therapeutics, Inc
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
This is a single-site feasibility pilot study to determine if patients with COPD with an increased risk of exacerbation will use an in-home COPD telemonitoring system for three months that collects lung measures, pulse oximetry, and medication compliance.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Device: Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter Not Applicable

Detailed Description:
This is a single-site, prospective, open label trial evaluating home telemonitoring for patients with COPD and a history of increased exacerbation risk. The purpose of this study is to determine whether automated home monitoring of medication compliance and biometric parameters [forced expiratory capacity in one second (FEV1), forced vital capacity (FVC), peak inspiratory flow rate (PIFR), inspiratory capacity (IC), pulse oximetry, and symptoms] is acceptable to patients, can improve adherence, and may improve clinical outcomes and reduce exacerbations and avoidable 30-day readmissions. Slow spirometry will be performed Sundays, Mondays, Wednesdays, Fridays and Saturdays. Forced spirometry will be performed Tuesdays and Thursdays.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive the intervention consisting of a home telemedicine tablet platform (GoHome) that will collect multiple spirometry tests each week (including both forced and slow spirometry measurements), pulse oximetry, and quality of life (QoL) Questionnaire responses. The platform will remind patients to take their medications remind patients to perform measurements, send patients helpful information, and execute a University of North Carolina (UNC) clinic established COPD Action Plan.The backend of the platform is a remote server (Monitored Therapeutics Incorporated CarePortal) that collects the data, send out alerts to the Principal Investigator and can track and trend the data for them.
Masking: None (Open Label)
Masking Description: This is an open-label study.
Primary Purpose: Supportive Care
Official Title: Assessing Adherence to Home Telemedicine in Individuals With COPD
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Home Telemedicine Device
This arm will receive the intervention of the home telemedicine device for three months.
Device: Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter
All participants will receive the intervention consisting of a home telemedicine tablet platform (GoHome) that will collect multiple spirometry tests each week (including both forced and slow spirometry measurements), pulse oximetry, and QoL Questionnaire responses. The platform will remind patients to take their medications remind patients to perform measurements, send patients helpful information, and execute a UNC clinic established COPD Action Plan.The backend of the platform is a remote server (Monitored Therapeutics CarePortal) that collects the data, send out alerts to the Principal Investigator and can track and trend the data for them.




Primary Outcome Measures :
  1. Home device measurement collection adherence [ Time Frame: 3 months ]
    Percentage of participants achieving >50% completion of all planned device measurements (spirometry, pulse oximetry and questionnaires) over three months

  2. Change from baseline in Total Score of COPD Assessment Test (CAT) [ Time Frame: 3 months ]
    Percentage of participants achieving ≥2 point decrease in CAT from baseline to three months. The CAT is a short, self-completed, 8-item questionnaire, each item is rated on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment). The total CAT score is calculated by summing the scores of all items and ranges from 0 to 40, higher scores indicating severe condition.


Secondary Outcome Measures :
  1. Participant satisfaction survey scores at 3 months [ Time Frame: 3 months ]
    The percentage of participants with score of 4 or higher on individual survey domains. A satisfaction survey (investigator-developed, 15 questions, each question is graded on a scale of 1-5, 1 being not at all and 5 being extremely) will be used to measure home spirometry and table ease and usefulness.

  2. Rate of self-reported COPD exacerbations [ Time Frame: 3 months ]
    The 30-day COPD exacerbation rate, defined as the mean number of events/30 days of follow-up (using three months of follow-up data). COPD exacerbation events are defined as self-reported COPD exacerbations requiring treatment with antibiotics or steroids.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female patients
  • 40 to 80 years of age
  • English speaking
  • Spirometry confirmed COPD (post-bronchodilator FEV1/FVC<0.70) and post-bronchodilator FEV1% predicted <80% at screening visit. (Target 50% of recruitment with post-bronchodilator FEV1<50% predicted (severe obstruction))
  • Increased COPD exacerbation risk defined as either of the following in the prior 12 months:

    • One hospitalization for COPD exacerbation
    • Two outpatient COPD exacerbations requiring treatment with steroids and/or antibiotics
  • Signed informed consent

Exclusion Criteria:

  • Unable to perform spirometry on their own following training.
  • Planned discharge to a nursing home or other extended care facility
  • Co-morbid conditions likely to result in non-preventable readmissions (e.g., terminal malignancy, cirrhosis or end-stage liver disease, chronic wound infections, etc.)
  • Uncontrolled or untreated medical conditions that would predispose the patient to recurrent COPD exacerbations (i.e., bronchiectasis)
  • Patient refusal to or inability to comply with monitoring requirements, for any reason including but not limited to dementia, a history of dementia, or other significant mental impairment
  • Patients enrolled in any other clinical trials or therapeutic studies of drugs, devices, or biologics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369885


Contacts
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Contact: Michael B Drummond, MD 984-974-2969 brad_drummond@med.unc.edu
Contact: Andrea McDaniel-Harper 984-974-2969 harper41@email.unc.edu

Locations
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United States, North Carolina
Meadowmont Marsico Lung Research Center Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Andrea McDaniel-Harper    984-974-2969    harper41@email.unc.edu   
Contact: Karen Hardy    984-974-2971    hardykd@live.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Midmark Corporation
Monitored Therapeutics, Inc
Investigators
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Principal Investigator: Michael B Drummond, MD University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04369885    
Other Study ID Numbers: 20-0107
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of North Carolina, Chapel Hill:
home telemedicine
home spirometer
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive