COPD, Pulmonary Rehabilitation
Conditions
Brief summary
The proposed study seeks to assess the performance of continuous biosensor data and machine learning analytics in assessment of health patient status in a pulmonary rehabilitation program. It is hypothesized that using continuous physiologic biosensor data and machine learning analytics to detect changes in physiology may play a role in managing patients in the pulmonary rehabilitation setting.
Interventions
OTHERpinpointIQ
The study will utilize physIQ's multivariate analytical methods that detect vital sign relationship changes compared to a patient's individual baseline. Changes in vital signs relationships may be indicative of current or future important clinical events. These changes are indicated through the Multivariate Change Index (MCI), which is a scalar index between 0 and 1, where values close to 0 indicate no significant change from baseline and values close to 1 indicated greater changes from baseline
Sponsors
Sunovian
Karen Larimer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Inclusion criteria
* Male or female, at least 40 years of age; * Diagnosis of Chronic Obstructive Pulmonary Disease (COPD); * Enrolled in the study site's 12-week pulmonary rehabilitation program; * Capable of completing a 6-minute walk test; * Willing and able to comply with scheduled protocol procedures and follow up; * Signed and dated informed consent and HIPAA materials indicating that the patient has agreed to participate in this study and has been informed of all pertinent aspects of the trial.
Exclusion criteria
* Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to utilize the System as instructed; * Patient is actively enrolled in another clinical investigation that, in the opinion of the investigator, interferes with or compromises either that patient's ability to participation in this study or the ability for the study to generate results; * Patients who have implanted defibrillators or pacemakers; * Patient is allergic to hydrocolloid adhesive; * Patient does not speak English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Utility | 90 days | Correlation of reported health events with the multivariate change index |
Countries
United States
Outcome results
None listed