Pulmonary Disease, Chronic ObstructiveCHARM COPDNCT05290831
Changes in Heart Rate Variability And Heart Rate/Activity Slope After Hospitalization for Acute Exacerbations of COPD
A study testing VitalPatch in people with Pulmonary Disease, Chronic Obstructive, run by Minneapolis Veterans Affairs Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- VitalPatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2022to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 10 pack year smoking history
- Hospitalized with one or more of:
- increased dyspnea
- increased sputum
Show all 9Show fewer
- change in sputum character
- Treated with corticosteroids and/or antibiotics for respiratory indications
- Age > 40 years old
Who cannot join
- Discharging home on hospice
- Inability to follow trial protocols
- Pacemaker
- Allergy to a component of the adhesive patches
- Breastfeeding
- Permanent/continuous atrial fibrillation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- VitalPatch
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalPatchDevice
The VitalPatch continuously monitors skin temperature, activity, and electrocardiography.
| Study group | Role | What they receive |
|---|---|---|
| Main study group | Experimental | Not described Receives: Device: VitalPatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start10 Apr 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, David MacDonald, Minneapolis Veterans Affairs Medical Center
- Investigators
- David MacDonald, MD, MS, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290831
- Sponsor's protocol ID
- 1653926
- Acronym
- CHARM COPD
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Heart Rate Variability And Heart Rate/Activity Slope Measures After Hospitalization for Acute Exacerbations of COPD: An Observational Study
- ClinicalTrials.gov ID
- NCT05290831
- Acronym / sponsor ID
- CHARM COPD / 1653926
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Study start
- 10 Apr 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main study group | Experimental | Device: VitalPatch |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
- 10 pack year smoking history
- Hospitalized with one or more of:
- Treated with corticosteroids and/or antibiotics for respiratory indications
Key exclusion criteria (6 listed)
- Discharging home on hospice
- Inability to follow trial protocols
- Pacemaker
- Allergy to a component of the adhesive patches
- Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitalPatchThe VitalPatch continuously monitors skin temperature, activity, and electrocardiography. | Device | Main study group |
Primary outcome
Model fit from repeated measures mixed model of heart rate/activity slope
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Comparison of heart rate/activity slope in participants readmitted vs not-readmitted
Time frame: 28 days
Comparison of heart rate variability slope in participants readmitted vs not-readmitted
Time frame: 28 days
Acceptability to participants
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David MacDonald, MD, MS principal investigator
Minneapolis Veterans Affairs Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing VitalPatch in people with Pulmonary Disease, Chronic Obstructive, run by Minneapolis Veterans Affairs Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David MacDonald, MD, MS (612-725-2000, david.macdonald2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Model fit from repeated measures mixed model of heart rate/activity slope (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.