Assessing Adherence to Home Telemedicine in Individuals With COPD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Percentage of Participants With Decrease in COPD Assessment Test (CAT) Score
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
This is an open-label study.
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Percentage of Participants With Decrease in COPD Assessment Test (CAT) Score
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.
Percentage of Participants With 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
Secondary Outcomes
- Rate of Self-reported COPD Exacerbations(3 months)
- Median Number of Ideal Daily Questions Score at 3 Months(3 months)
- Percentage of Participants With Individual Survey Domains Score of 4 or Higher(3 months)
- Median Communication Frequency Survey Score at 3 Months(3 months)