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Connected Devices

Intervention Arm for Chronic Obstructive Pulmonary Disease

N/A
Waitlist Available
Led By Alvaro Velasquez, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights

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.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Exacerbation of COPD episodes by Assessment Test (CAT) scores Changes
Secondary outcome measures
Change in Patient Satisfaction Scores
Number of Patient Emergency Visits
Number of Uncontrolled Flags
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
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.
Group II: Control ArmActive Control1 Intervention
These patients will be followed by the Clinical Research Coordinator for CAT scores, emergency department visits and hospitalizations.

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Who is running the clinical trial?

Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,496 Total Patients Enrolled
Innovation Hub EnterprisesLead Sponsor
Alvaro Velasquez, MDPrincipal InvestigatorEmory University

Frequently Asked Questions

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~71 spots leftby Apr 2025