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