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Changes in Heart Rate Variability And Heart Rate/Activity Slope After Hospitalization for Acute Exacerbations of COPD (CHARM COPD)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VitalPatch
Sponsored by
Minneapolis Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

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

Inclusion Criteria:

  1. Signed informed consent
  2. At least moderate COPD by Global Initiative for Chronic Obstructive Lung Disease spirometry criteria (FEV1/FVC < 0.7 and FEV1 < 80% predicted)
  3. 10 pack year smoking history

  4. Hospitalized with one or more of:

    1. increased dyspnea
    2. increased sputum
    3. change in sputum character
  5. Treated with corticosteroids and/or antibiotics for respiratory indications
  6. Age > 40 years old

Exclusion Criteria:

  1. Discharging home on hospice
  2. Inability to follow trial protocols
  3. Pacemaker
  4. Allergy to a component of the adhesive patches
  5. Breastfeeding
  6. Permanent/continuous atrial fibrillation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Main study group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Model fit from repeated measures mixed model of heart rate/activity slope
    The investigators will average heart rate and activity (from accelerometer output) over 30-second periods. The highest 30-second average from each 5 minute period will be used to create the heart rate/activity slope for each 24-hour period while the device is worn. They will then model the change in heart rate/activity slope using a linear-mixed effect model with a random intercept and slope for each individual.
    Heart rate variability slopes (time and frequency-domain)
    The investigators will use Kubios software to calculate heart rate variability (time and frequency domain measurements) for each 24-hour period that the patch is worn. They will use repeated mixed measures models with random intercept and slope to model the change in heart rate variability after discharge.

    Secondary Outcome Measures

    Comparison of heart rate/activity slope in participants readmitted vs not-readmitted
    The investigators will compare heart rate/activity slope in participants who are readmitted to the hospital within 28 days to those who are not readmitted to the hospital within 28 days using a linear mix-effect model with random intercept and slope.
    Comparison of heart rate variability slope in participants readmitted vs not-readmitted
    The investigators will compare heart rate variability slopes (time and frequency domain) in participants who are readmitted to the hospital within 28 days to those who are not readmitted to the hospital within 28 days using a linear mix-effect model with random intercept and slope.
    Acceptability to participants
    We will query participants if the monitoring patch would be acceptable if it were shown to improve their care for COPD.

    Full Information

    First Posted
    March 11, 2022
    Last Updated
    March 21, 2022
    Sponsor
    Minneapolis Veterans Affairs Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05290831
    Brief Title
    Changes in Heart Rate Variability And Heart Rate/Activity Slope After Hospitalization for Acute Exacerbations of COPD
    Acronym
    CHARM COPD
    Official Title
    Changes in Heart Rate Variability And Heart Rate/Activity Slope Measures After Hospitalization for Acute Exacerbations of COPD: An Observational Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 10, 2022 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    April 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Minneapolis Veterans Affairs Medical Center

    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.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to observe the variation in time between heart beats and how heart rate changes during activity evolve after hospitalization for an exacerbation of COPD.
    Detailed Description
    The investigators will place a monitoring patch that continuously records electrocardiogram and activity. Participants will switch this patch every 7 days for a total of 28 days. From these data the investigators will observe how heart rate variability and heart rate responses to exercise evolve after hospitalization for an exacerbation of COPD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Disease, Chronic Obstructive

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Main study group
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    VitalPatch
    Intervention Description
    The VitalPatch continuously monitors skin temperature, activity, and electrocardiography.
    Primary Outcome Measure Information:
    Title
    Model fit from repeated measures mixed model of heart rate/activity slope
    Description
    The investigators will average heart rate and activity (from accelerometer output) over 30-second periods. The highest 30-second average from each 5 minute period will be used to create the heart rate/activity slope for each 24-hour period while the device is worn. They will then model the change in heart rate/activity slope using a linear-mixed effect model with a random intercept and slope for each individual.
    Time Frame
    28 days
    Title
    Heart rate variability slopes (time and frequency-domain)
    Description
    The investigators will use Kubios software to calculate heart rate variability (time and frequency domain measurements) for each 24-hour period that the patch is worn. They will use repeated mixed measures models with random intercept and slope to model the change in heart rate variability after discharge.
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Comparison of heart rate/activity slope in participants readmitted vs not-readmitted
    Description
    The investigators will compare heart rate/activity slope in participants who are readmitted to the hospital within 28 days to those who are not readmitted to the hospital within 28 days using a linear mix-effect model with random intercept and slope.
    Time Frame
    28 days
    Title
    Comparison of heart rate variability slope in participants readmitted vs not-readmitted
    Description
    The investigators will compare heart rate variability slopes (time and frequency domain) in participants who are readmitted to the hospital within 28 days to those who are not readmitted to the hospital within 28 days using a linear mix-effect model with random intercept and slope.
    Time Frame
    28 days
    Title
    Acceptability to participants
    Description
    We will query participants if the monitoring patch would be acceptable if it were shown to improve their care for COPD.
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent At least moderate COPD by Global Initiative for Chronic Obstructive Lung Disease spirometry criteria (FEV1/FVC < 0.7 and FEV1 < 80% predicted) 10 pack year smoking history Hospitalized with one or more of: increased dyspnea increased sputum change in sputum character Treated with corticosteroids and/or antibiotics for respiratory indications Age > 40 years old Exclusion Criteria: Discharging home on hospice Inability to follow trial protocols Pacemaker Allergy to a component of the adhesive patches Breastfeeding Permanent/continuous atrial fibrillation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David MacDonald, MD, MS
    Phone
    612-725-2000
    Email
    david.macdonald2@va.gov
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David MacDonald, MD, MS
    Organizational Affiliation
    Minneapolis Veterans Affairs Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Changes in Heart Rate Variability And Heart Rate/Activity Slope After Hospitalization for Acute Exacerbations of COPD

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