Changes in Heart Rate Variability And Heart Rate/Activity Slope After Hospitalization for Acute Exacerbations of COPD
CHARM COPD
1 other identifier
interventional
45
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2022
CompletedFirst Posted
Study publicly available on registry
March 22, 2022
CompletedStudy Start
First participant enrolled
April 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedMarch 22, 2022
March 1, 2022
1.7 years
March 11, 2022
March 21, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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.
28 days
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.
28 days
Secondary Outcomes (3)
Comparison of heart rate/activity slope in participants readmitted vs not-readmitted
28 days
Comparison of heart rate variability slope in participants readmitted vs not-readmitted
28 days
Acceptability to participants
28 days
Study Arms (1)
Main study group
EXPERIMENTALInterventions
The VitalPatch continuously monitors skin temperature, activity, and electrocardiography.
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- Discharging home on hospice
- Inability to follow trial protocols
- Pacemaker
- Allergy to a component of the adhesive patches
- Breastfeeding
- Permanent/continuous atrial fibrillation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David MacDonald, MD, MS
Minneapolis Veterans Affairs Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 11, 2022
First Posted
March 22, 2022
Study Start
April 10, 2022
Primary Completion
January 1, 2024
Study Completion
April 1, 2024
Last Updated
March 22, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share