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

University of North Carolina (UNC)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter

Study type: Interventional

Funder types: Other

Identifiers

NCT04369885

20-0107

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Home Telemedicine Device

Experimental group

Description:

This arm will receive the intervention of the home telemedicine device for three months.

Treatment:

Device: Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter