Clinical trial NCT05271474: COPD Remote Patient Monitoring Through Connected Devices
Official title: Managing Diagnosed COPD Patients Through Connected Devices to Provide Pulmonologists With Objective Data to Inform Treatment Decisions and Enable Exacerbation Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Innovation Hub Enterprises
Sponsor class: INDUSTRY
First posted: 2022-03-09
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Exacerbation of COPD episodes by Assessment Test (CAT) scores Changes
timeFrame: At baseline and at 16 weeks
Secondary outcomes:
measure: Number of exacerbations onset detected
timeFrame: From baseline to study completion (16 weeks)
measure: Vital data: SpO2 drop >4%
timeFrame: From baseline to study completion (16 weeks)
measure: Vital data: SpO2 drop <90%
timeFrame: From baseline to study completion (16 weeks)
measure: Vital data: FEV1
timeFrame: From baseline to study completion (16 weeks)
measure: Vital data: Respiratory Rate
timeFrame: From baseline to study completion (16 weeks)
measure: Provider Satisfaction Scores
timeFrame: Week 16
measure: Change in Patient Satisfaction Scores
timeFrame: Week 16
measure: Number of Patient Emergency Visits
timeFrame: Week 16
measure: Number of Uncontrolled Flags
timeFrame: From baseline to study completion (16 weeks)
measure: Response to Flags
timeFrame: From baseline to study completion (16 weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Alvaro Velasquez, MD
role: PRINCIPAL_INVESTIGATOR
References: