COPD Remote Patient Monitoring Through Connected Devices

Innovation Hubs

Status: Not yet enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: ANNE ONE Platform

Study type: Interventional

Funder types: Industry

Identifiers

NCT05271474

STUDY00003325

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Participants will be assigned to use Sibel sensor and download the ANNE ONE platform to their mobile devices. The Sibel sensors are to be worn on the sternum and index finger and can be attached using provided replaceable gel adhesive. The Sibel sensors will transmit data to the ANNE ONE platform. The ANNE ONE platform will send automated alerts to the CRC via email when a patient is flagged as uncontrolled, which will occur when a patient's vitals reach or pass one of the safety thresholds.

Treatment:

Device: ANNE ONE Platform

Control Arm

No Intervention group

Description:

These patients will be followed by the Clinical Research Coordinator for CAT scores, emergency department visits and hospitalizations.