N/A
Completed N=12
Assessing Adherence to Home Telemedicine in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT04369885 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Percentage of Participants With Home Device Measurement Collection Adherence — 63 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Home Device Measurement Collection Adherence |
63 | — |
| PRIMARY Percentage of Participants With Decrease in COPD Assessment Test (CAT) Score |
57 | — |
| SECONDARY Percentage of Participants With Individual Survey Domains Score of 4 or Higher |
36; 46; 46; 46; 55; 73 | — |
| SECONDARY Median Communication Frequency Survey Score at 3 Months |
3 | — |
| SECONDARY Median Number of Ideal Daily Questions Score at 3 Months |
5 | — |
| SECONDARY Rate of Self-reported COPD Exacerbations |
0.14 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04369885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.