Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
Brief summary
This study is a device study that will use a double-arm. It will integrate the ANNE ONE platform which continuously tracks enrolled COPD patients' vital signs and symptoms over the course of the study and digitally shares that data with providers for clinical interpretation, potential intervention and treatment decision making and will help evaluate the impact on participating patient's COPD Assessment Test (CAT) scores. Subjects will be recruited from Emory clinics and identified via a data pull based on clinical relevant codes. Letters will be sent out to eligible candidates and interested participants will contact the research team. The research team will consent them over the phone and mail the device to them; participants will be compensated.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a diseases that causes airflow limitation and breathing-related problems, affecting approximately 16 million people in the U.S., most of which are aged 40 and above with a history of smoking. COPD causes acute exacerbations where a patient has worsening symptoms (increased shortness of breath, cough, or sputum production). Managing COPD presents many challenges, as patients struggle to adhere to their prescribed treatment plans. Digital platforms are gradually becoming more available to enable providers to help patients manage their condition. These platforms create objective transparency, lessening the need for patients to consciously track their COPD exacerbation events, enabling providers to proactively manage their patients' condition, and creating actionable reports for providers to review with their patients. Ultimately, connected devices present a strong opportunity to provide patients with appropriate care earlier in the patient journey, while enabling pulmonologists to deliver more customized management based on close to real time objective data. The primary goal of this study is to evaluate the impact of the implementation of the ANNE ONE platform on patients with COPD's condition. This will be achieved by using the ANNE ONE platform to continuously track enrolled COPD patients' vital signs over the course of the study and digitally sharing that data with providers for clinical interpretation, potential intervention and treatment decision making. Interviews have been conducted with leading pulmonologists and staff at Emory Healthcare to understand what factors are considered when recommending a treatment pathway for a COPD patient, what the current workflow shortcomings are and how a new workflow using the ANNE ONE platform could effectively be integrated at a pulmonologist's office.
Interventions
DEVICEANNE ONE Platform
ANNE ONE is one most advanced digital platforms that are gradually becoming more available to enable providers to help patients manage their condition. It integrates soft and flexible sensors for comprehensive vital signs monitoring. This platform creates objective transparency by automatically recording data from the sensor on the patient, lessening the need for patients to consciously track their COPD exacerbation events, enabling providers to proactively manage their patients' condition, and creating actionable reports for providers to review with their patients.
Sponsors
Innovation Hub Enterprises
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 40\>years * Have a formal diagnosis of COPD * Must be able to understand and speak English in order to complete the survey questionnaires. * They must be able and willing to download the ANNE ONE application on a smartphone. * Have their COPD managed by a pulmonologist. * Have the willingness and ability to commit to the study period and completion of the surveys.
Exclusion criteria
* Participants with a formal diagnosis of asthma will be excluded. * Those who are unable to read and/or speak English * Patients who exhibit physical or mental disability precluding the ability to provide informed consent will be excluded from the study. * Those who are unable or unwilling to download the ANNE ONE application will also be excluded. * Additionally, participant who are not willing or able to commit to the duration of the study will not be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exacerbation of COPD episodes by Assessment Test (CAT) scores Changes | At baseline and at 16 weeks | CRC will be responsible for collecting through patient-reported and electronic medical record (EMR)-reported (clinical notes and/or hospitalizations). Greater impact on COPD Assessment Test (CAT) scores (reduction of patient symptoms) compared to control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital data: SpO2 drop >4% | From baseline to study completion (16 weeks) | Data from ANNE ONE sensors will be reviewed for SpO2 drops below 7-day rolling average by more than 4% for 2 consecutive days. |
| Vital data: SpO2 drop <90% | From baseline to study completion (16 weeks) | Data from ANNE ONE sensors will be reviewed for SpO2 drops below 90% for 2 consecutive days. |
| Vital data: FEV1 | From baseline to study completion (16 weeks) | Data from ANNE ONE sensors will be reviewed for Forced expiratory volume in the first second (FEV1) drops below 7-day rolling average by more than 1.645 standard deviations for 2 consecutive days. |
| Vital data: Respiratory Rate | From baseline to study completion (16 weeks) | Data from ANNE ONE sensors will be collected reviewed for respiratory rate increases 15% for 2 consecutive days above 7-day rolling average. |
| Number of exacerbations onset detected | From baseline to study completion (16 weeks) | Clinical Research Coordinators (CRC) will be responsible for collecting through patient-reported and electronical medical record reported (clinical notes and/or hospitalizations).Episodes will be counted and compared from Intervention Group vs Control group. |
| Change in Patient Satisfaction Scores | Week 16 | CRC will distribute survey to patients, once at the end of the pilot to understand patient experience and adherence. |
| Number of Patient Emergency Visits | Week 16 | CRC will be responsible for patient history surveys, as well as coordinating an electronical medical record for the population. CRC will keep up with emergency visits for each subject and record these. |
| Number of Uncontrolled Flags | From baseline to study completion (16 weeks) | Number of events that the system shows as irregular readings |
| Response to Flags | From baseline to study completion (16 weeks) | Number of response received by providers to flags in the system triggered by patient's irregular readings |
| Provider Satisfaction Scores | Week 16 | CRC will connect with pulmonologists throughout the pilot and provide a closing survey |
Countries
United States
Contacts
Primary ContactAlvaro Velasquez, MD
Outcome results
None listed