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A Pre-post Intervention Study Evaluating Home-based Management of Patients With COPD or CAP

Primary Purpose

Chronic Obstructive Pulmonary Disease, Community-acquired Pneumonia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Current Health platform
Sponsored by
Current Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring wearable, Current Health platform, 30 day readmission

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 21 years or older
  • confirmed diagnosis of moderate-severe COPD or community acquired pneumonia
  • attendance at South Shore Hospital with an exacerbation of COPD / CAP
  • fit for discharge to home

Exclusion Criteria:

  • suspicion of COVID-19 or confirmed COVID-19 positive
  • life-threatening exacerbation requiring invasive ventilation or prolonged stay in critical care (> 24 hours)
  • unable/unwilling to use Current Health
  • bilateral axillary lymph node dissection
  • persistent atrial fibrillation
  • heavy tattooing on upper arms
  • discharged to skilled nursing facility
  • no access to home or mobile telephone

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    Participants will be remotely monitored with the Current Health platform, respond to daily respiratory surveys, receive daily medication reminders and an action plan. Daily dashboard rounds and vital sign alarms from the continuously collected vital signs will be used to identify changes in health and escalated accordingly.

    Outcomes

    Primary Outcome Measures

    Number of participants with a hospital readmission

    Secondary Outcome Measures

    Time to service use
    Rate of clinical visits
    telehealth and/or ambulatory visits
    Length of Stay
    original and subsequent readmissions or emergency department attendance
    Rate of Mortality
    Rate of medication adherence
    Progression of Disease
    medication requirements, oxygen dependence, spirometric changes

    Full Information

    First Posted
    August 10, 2021
    Last Updated
    November 9, 2021
    Sponsor
    Current Health
    Collaborators
    South Shore Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05009485
    Brief Title
    A Pre-post Intervention Study Evaluating Home-based Management of Patients With COPD or CAP
    Official Title
    A Pre-post Intervention Study Evaluating Home-based Management of Patients With Chronic Obstructive Pulmonary Disease or Community Acquired Pneumonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    study never started because reprioritization of clinical research efforts
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    May 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Current Health
    Collaborators
    South Shore Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Risk of rehospitalization within 30 days of discharge is higher than 20% in patients with chronic obstructive pulmonary disease (COPD) and up to 20% for patients with community acquired pneumonia (CAP). This pre-post intervention study aims to quantify the impact of continuous remote patient monitoring (RPM) on rates of hospital readmission for patients presenting with CAP or exacerbation of COPD and compare the intervention group to historical controls that did not have access to the intervention. We hypothesize that an intervention combining remote patient monitoring with the remote clinical services and escalation pathways available at SSH (including the Mobile Integrated Health (MIH) program) will reduce hospital readmission within the 30 days following hospital discharge compared to standard of care in this population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease, Community-acquired Pneumonia
    Keywords
    wearable, Current Health platform, 30 day readmission

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Participants will be remotely monitored with the Current Health platform, respond to daily respiratory surveys, receive daily medication reminders and an action plan. Daily dashboard rounds and vital sign alarms from the continuously collected vital signs will be used to identify changes in health and escalated accordingly.
    Intervention Type
    Device
    Intervention Name(s)
    Current Health platform
    Intervention Description
    A remote patient monitoring system which includes a small footprint device and tablet, combined with an AI-powered, cloud-based system driving advanced real-time and predictive analytics related to a patient's clinical condition. The wearable records heart rate, respiratory rate, oxygen saturation, skin temperature and step count.
    Primary Outcome Measure Information:
    Title
    Number of participants with a hospital readmission
    Time Frame
    up to 30 days
    Secondary Outcome Measure Information:
    Title
    Time to service use
    Time Frame
    up to 30 days
    Title
    Rate of clinical visits
    Description
    telehealth and/or ambulatory visits
    Time Frame
    up to 30 days
    Title
    Length of Stay
    Description
    original and subsequent readmissions or emergency department attendance
    Time Frame
    up to 30 days
    Title
    Rate of Mortality
    Time Frame
    up to 30 days
    Title
    Rate of medication adherence
    Time Frame
    up to 30 days
    Title
    Progression of Disease
    Description
    medication requirements, oxygen dependence, spirometric changes
    Time Frame
    up to 30 days
    Other Pre-specified Outcome Measures:
    Title
    Patient Satisfaction as assessed by the Telehealth Usability Questionnaire
    Description
    subdomain of the Telehealth Usability Questionnaire that includes 4 questions measured on a 7-point Likert scale.
    Time Frame
    up to 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 21 years or older confirmed diagnosis of moderate-severe COPD or community acquired pneumonia attendance at South Shore Hospital with an exacerbation of COPD / CAP fit for discharge to home Exclusion Criteria: suspicion of COVID-19 or confirmed COVID-19 positive life-threatening exacerbation requiring invasive ventilation or prolonged stay in critical care (> 24 hours) unable/unwilling to use Current Health bilateral axillary lymph node dissection persistent atrial fibrillation heavy tattooing on upper arms discharged to skilled nursing facility no access to home or mobile telephone

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    A Pre-post Intervention Study Evaluating Home-based Management of Patients With COPD or CAP

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