COPD Remote Patient Monitoring Through Connected Devices

NCT05271474 | Unknown FDA Device

• 1 other identifier: STUDY00003325
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Exacerbation of COPD episodes by Assessment Test (CAT) scores Changes

  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.

  At baseline and at 16 weeks

Secondary Outcomes (10)

• Number of exacerbations onset detected

  From baseline to study completion (16 weeks)

• Vital data: SpO2 drop >4%

  From baseline to study completion (16 weeks)

• Vital data: SpO2 drop <90%

  From baseline to study completion (16 weeks)

• Vital data: FEV1

  From baseline to study completion (16 weeks)

• Vital data: Respiratory Rate

  From baseline to study completion (16 weeks)

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Device: ANNE ONE Platform

Control Arm

NO INTERVENTION

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

Interventions

ANNE ONE Platform DEVICE

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.

Intervention Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovation Hub Enterprises: lead

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alvaro Velasquez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alvaro Velasquez, MD

CONTACT

404-686-2505; avelasq@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 9, 2022
• Study Start: June 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)