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

Changes in Heart Rate Variability And Heart Rate/Activity Slope Measures After Hospitalization for Acute Exacerbations of COPD: An Observational Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: VitalPatch

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David MacDonald, MD, MS; Phone Number: 612-725-2000; Email: david.macdonald2@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main study group	Device: VitalPatch; The VitalPatch continuously monitors skin temperature, activity, and electrocardiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days
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.	28 days
Acceptability to participants	We will query participants if the monitoring patch would be acceptable if it were shown to improve their care for COPD.	28 days

Collaborators and Investigators

• Sponsor: Minneapolis Veterans Affairs Medical Center
• Investigators: Principal Investigator: David MacDonald, MD, MS, Minneapolis Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 10, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 1653926

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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