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

Not Applicable

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: VitalPatch

• Registration Number: NCT05290831
• Lead Sponsor: Minneapolis Veterans Affairs Medical Center

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.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-21
• Last Update Submitted: 2022-03-21
• Study First Posted: 2022-03-22
• Last Update Posted: 2022-03-22
• Study Start: 2022-04-10
• Primary Completion: 2024-01-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main study group	VitalPatch	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.