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

• Sponsor: Minneapolis Veterans Affairs Medical Center (U.S. Fed)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05290831
• Collaborator: (none)
• Enrollment: 45
• Arm: 1
• Anticipated Duration (Months): 23.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Device: VitalPatch	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Changes in Heart Rate Variability And Heart Rate/Activity Slope Measures After Hospitalization for Acute Exacerbations of COPD: An Observational Study
• Anticipated Study Start Date: Apr 10, 2022
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts 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:

5. increased dyspnea

6. increased sputum

7. change in sputum character

8. Treated with corticosteroids and/or antibiotics for respiratory indications

9. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Minneapolis Veterans Affairs Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David MacDonald, Principal Investigator, Minneapolis Veterans Affairs Medical Center
• ClinicalTrials.gov Identifier: NCT05290831
• Other Study ID Numbers: 1653926
• First Posted: Mar 22, 2022
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Mar 22, 2022