Status:
COMPLETED
Assessing Adherence to Home Telemedicine in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Midmark Corporation
Monitored Therapeutics, Inc
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
NA
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 lu...
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 wheth...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04369885
Start Date
July 1 2020
End Date
May 24 2021
Last Update
November 3 2021
Active Locations (1)
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1
Meadowmont Marsico Lung Research Center
Chapel Hill, North Carolina, United States, 27517