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Chronic Obstructive Pulmonary DiseaseNCT05271474

COPD Remote Patient Monitoring Through Connected Devices

A study testing ANNE ONE Platform in people with Chronic Obstructive Pulmonary Disease, run by Innovation Hub Enterprises at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
ANNE ONE Platform
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
Jun 2022to Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Alvaro Velasquez, MD contact

404-686-2505

avelasq@emory.edu

United States1 site

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Alvaro Velasquez, MD, 404-686-2505, avelasq@emory.edu

Other trials in United States

About this study

Official title: Managing Diagnosed COPD Patients Through Connected Devices to Provide Pulmonologists With Objective Data to Inform Treatment Decisions and Enable Exacerbation Intervention

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.

Read the 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.

Being tested
ANNE ONE Platform
Keywords
COPD
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ANNE ONE PlatformDevice

    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.

Study groups in NCT05271474
Study groupRoleWhat they receive
Intervention ArmExperimentalParticipants 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.
Receives: Device: ANNE ONE Platform
Control ArmNo interventionThese patients will be followed by the Clinical Research Coordinator for CAT scores, emergency department visits and hospitalizations.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At baseline and at 16 weeks

Secondary outcomes (10)

  1. Number of exacerbations onset detected

    Clinical Research Coordinators (CRC) will be responsible for collecting through patient-reported and electronical medical record reported (clinical notes and/or hospitalizations).Episodes will be counted and compared from Intervention Group vs Control group.

    Measured: From baseline to study completion (16 weeks)

  2. Vital data: SpO2 drop >4%

    Data from ANNE ONE sensors will be reviewed for SpO2 drops below 7-day rolling average by more than 4% for 2 consecutive days.

    Measured: From baseline to study completion (16 weeks)

  3. Vital data: SpO2 drop <90%

    Data from ANNE ONE sensors will be reviewed for SpO2 drops below 90% for 2 consecutive days.

    Measured: From baseline to study completion (16 weeks)

  4. Vital data: FEV1

    Data from ANNE ONE sensors will be reviewed for Forced expiratory volume in the first second (FEV1) drops below 7-day rolling average by more than 1.645 standard deviations for 2 consecutive days.

    Measured: From baseline to study completion (16 weeks)

  5. Vital data: Respiratory Rate

    Data from ANNE ONE sensors will be collected reviewed for respiratory rate increases 15% for 2 consecutive days above 7-day rolling average.

    Measured: From baseline to study completion (16 weeks)

  6. Provider Satisfaction Scores

    CRC will connect with pulmonologists throughout the pilot and provide a closing survey

    Measured: Week 16

  7. Change in Patient Satisfaction Scores

    CRC will distribute survey to patients, once at the end of the pilot to understand patient experience and adherence.

    Measured: Week 16

  8. Number of Patient Emergency Visits

    CRC will be responsible for patient history surveys, as well as coordinating an electronical medical record for the population. CRC will keep up with emergency visits for each subject and record these.

    Measured: Week 16

  9. Number of Uncontrolled Flags

    Number of events that the system shows as "irregular" readings

    Measured: From baseline to study completion (16 weeks)

  10. Response to Flags

    Number of response received by providers to flags in the system triggered by patient's irregular readings

    Measured: From baseline to study completion (16 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2022
  2. Study startJun 2022 (estimated)
  3. Primary completionAug 2022 (estimated)
  4. Study completionAug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05271474
Sponsor's protocol ID
STUDY00003325
Status last verified
Jun 2022
First submitted
8 Feb 2022
Last updated
23 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ANNE ONE Platform in people with Chronic Obstructive Pulmonary Disease, run by Innovation Hub Enterprises at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alvaro Velasquez, MD (404-686-2505, avelasq@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exacerbation of COPD episodes by Assessment Test (CAT) scores Changes (time frame: At baseline and at 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05271474.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.

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