Pulmonary Disease, Chronic Obstructive
Conditions
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.
Interventions
DEVICEVitalPatch
The VitalPatch continuously monitors skin temperature, activity, and electrocardiography.
Sponsors
Minneapolis Veterans Affairs Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Model fit from repeated measures mixed model of heart rate/activity slope | 28 days | 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) | 28 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison of heart rate/activity slope in participants readmitted vs not-readmitted | 28 days | 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 | 28 days | 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 | 28 days | We will query participants if the monitoring patch would be acceptable if it were shown to improve their care for COPD. |
Contacts
Primary ContactDavid MacDonald, MD, MS
Outcome results
None listed