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COPD Remote Patient Monitoring Through Connected Devices

NCT05271474 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-06-23

No results posted yet for this study

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

Interventions

DEVICE

ANNE 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 & Collaborators

  • Innovation Hub Enterprises

    lead INDUSTRY

Principal Investigators

  • Alvaro Velasquez, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2022-08-31
Completion
2022-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05271474 on ClinicalTrials.gov