Respiration Rate Monitoring in COPD Patients
| Status: | Completed |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 35 - Any |
| Updated: | 11/18/2017 |
| Start Date: | December 1, 2016 |
| End Date: | July 26, 2017 |
Assessment of the Temporal Changes in Nightly Respiration Rate in Combination With a Daily Symptom Reporting Application for Facilitating Early Treatment of Symptoms in COPD Patients
Assess the feasibility of using remote respiration rate monitoring as a component of home
care, how respiration rate data may be used in combination with other data to potentially
improve response to symptoms, and to generate data to inform the endpoints and effect sizes
of future studies.
care, how respiration rate data may be used in combination with other data to potentially
improve response to symptoms, and to generate data to inform the endpoints and effect sizes
of future studies.
The research question is whether monitoring of respiration rates and variability can be
helpful in management of COPD patients in conjunction with or separately from self-reported
symptom scores using the COPD Co-PILOT application. Current techniques (such as patient's
self-reported symptoms) have limited sensitivity and specificity with regard to predicting
decompensation. Measurement of respiration parameters and the variability of the parameters
may detect worsening COPD. Changes in respiration patterns may occur sufficiently far in
advance of decompensation (e.g. >5 days prior to patient symptoms) such that it would allow
an opportunity for earlier intervention with medical assessment and current therapeutic
approaches.
The specific primary aim includes evaluation of the correlation of respiration rate
parameters to indicators of healthcare utilization including drug changes, office or ER
visits, hospitalization, or other clinical interventions. Secondary aims include evaluation
of (i) the sensitivity and specificity of respiration rate monitoring results to predict COPD
worsening requiring medical intervention, (ii) the sensitivity and specificity of respiration
rate monitoring results in conjunction with COPD Co-PILOT scores or components to predict
COPD worsening requiring medical intervention, and the correlation of respiration rate
parameters to episode duration as defined by number of days from COPD Co-PILOT Score >1 to
resolution (COPD Co-PILOT Score <1 for 7 consecutive days).
helpful in management of COPD patients in conjunction with or separately from self-reported
symptom scores using the COPD Co-PILOT application. Current techniques (such as patient's
self-reported symptoms) have limited sensitivity and specificity with regard to predicting
decompensation. Measurement of respiration parameters and the variability of the parameters
may detect worsening COPD. Changes in respiration patterns may occur sufficiently far in
advance of decompensation (e.g. >5 days prior to patient symptoms) such that it would allow
an opportunity for earlier intervention with medical assessment and current therapeutic
approaches.
The specific primary aim includes evaluation of the correlation of respiration rate
parameters to indicators of healthcare utilization including drug changes, office or ER
visits, hospitalization, or other clinical interventions. Secondary aims include evaluation
of (i) the sensitivity and specificity of respiration rate monitoring results to predict COPD
worsening requiring medical intervention, (ii) the sensitivity and specificity of respiration
rate monitoring results in conjunction with COPD Co-PILOT scores or components to predict
COPD worsening requiring medical intervention, and the correlation of respiration rate
parameters to episode duration as defined by number of days from COPD Co-PILOT Score >1 to
resolution (COPD Co-PILOT Score <1 for 7 consecutive days).
Inclusion Criteria:
- Males or females age ≥35 years old
- Documented diagnosis of moderate to very severe COPD (GOLD Level II-IV)
- Weight ≥35 kg
- Currently using the COPD Co-PILOT application (at least 3 months with 70% compliance)
- Must be able to read and understand English and consent for themselves
Exclusion Criteria:
- Currently using any form of non-invasive positive airway pressure ventilation
- Diagnosis of significant heart failure (NYHA Class III or IV)
- Cognitive impairment (determined by physician) that will make it hard to follow
instructions regarding device usage
- BMI ≥45.5
- Residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care
facilities
- Currently using a wearable drug infusion pump to deliver medication
- Planned procedures at time of enrollment that will occur within timeframe of study and
require hospitalization etc.
- Declines to participate at any time.
- In the opinion of the Investigator, may be non-compliant with study schedules or
procedures
- No cellular coverage at their primary residence
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