Study of ADI CardioPulmonary Management (CPM) System
Study Overview
Detailed Description
Patients that participate in this study will be using a wearable device for 6 months. At their initial visit (visit 1), patients will undergo a brief physical exam, have their medical history and medications recorded, and be fit to a device. With their clinical (or clinician delegate), the patient will have their baseline reading with the device. The patient will then be taught how to use the device at home and go through 2 practice patient-initiated measurements. The patient will also complete two surveys as a part of visit 1. These surveys can be done at the visit or at home within 7 days of the visit.
Details of all available history of Chronic Heart Failure (CHF) disease including surgical interventions related to CHF, CHF risk factors, or CHF comorbidities will be recorded (via a chart pull after the visit). The number of previous CHF-related hospitalizations, the patient's latest CHF diagnosis classification, and date of last hospitalization (number of days since) will be specifically noted. This includes notes about the current condition of the patient and their congestion and fluid status. Current New York Heart Association (NYHA) classification will be pulled as well (or assigned during the physical exam portion). Recent BNP (brain natriuretic peptide), creatinine, Left Ventricular Ejection Fraction (LVEF), chest Xray and other relevant labs will also be pulled from the chart and with vaccination status and dates for the following vaccines: COVID 19, flu and pneumonia. This is the first chart review (of two) that is required for the study).
After visit 1, the patient will use the device once daily for 6 months. After 6 months, the patient will return for visit 2. At visit two, the patient will have a brief physical exam and return the device. The patient will complete the same two surveys and an additional survey about their perception of the device.
30 days after visit 2 a second, targeted chart review will occur. Details of the patient's clinical course while they were using the device and for an additional 30 days after will be recorded. While the chart review will be targeted to the CHF clinical course (such as Emergency room visits, hospitalizations, skilled nursing facility visits, outpatient checkups and other CHF related notes), other relevant information will be collected as well. The most recent NYHA classification will be pulled (or assigned at visit 2). The most recent BNP, creatinine, LVEF, chest Xray and other relevant labs will be pulled.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Heart failure (HF) patients regardless of ejection fraction, HFpEF (heart failure preserved ejection fraction) or HFrEF (heart failure reserved ejection fraction) with one or more of the following:
- New York Heart Association (NYHA) Class III HF
- NYHA Class IV HF OR
- NYHA Class II HF with one/. or more of the following:
- Chronic Kidney Disease (eGFR<60 within the past 6 months)
- HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP > 200 pg/ml* (N-terminal pro b-type natriuretic peptide) for patients not in atrial fibrillation (AF) or > 600 pg/ml* for patients in AF on screening ECG+
- NT-proBNP > 300 pg/ml* for patients not in AF or > 900 pg/ml* for patients in AF on the screening visit ECG+
- Chronic obstructive pulmonary disease (COPD)
Exclusion Criteria:
- Under 18 years of age
- Patients with severe COPD (GOLD stage III or IV)
- Limited mobility preventing application of device or no caregiver to assist
- Cognitive impairments that would limit the application and proper use of the device
- Skin allergies or skin sensitivities to silicone-based adhesives
- Pregnancy (method of assessment at the discretion of the PI)
- Not willing to shave chest hair if needed to apply device
- Patients on chronic IV (intravenous) ionotropic therapy - (Milrinone, Dobutamine, and Dopamine)
- Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator
- No cellular coverage (Patient's Home)**
- Skin breakdown on the left chest or breast area
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Using wearable CPM Device daily
The patients will be using the wearable device once daily at home for 6 months.
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Wearable monitor used for 5 minutes per day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction with Device
Time Frame: 6 months
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Patient satisfaction with system obtained through survey questions; ease of use, impact and satisfaction; scale of 1-7 used with 1 being negative and 7 being positive.
Higher scores indicate more satisfaction with device.
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6 months
|
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Correlation of device data and clinical outcomes
Time Frame: 7 months
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Retrospective review of data to determine correlation of patient specific device measurements (such as increase/decrease in specific device parameters) with heart failure events.
Measurements include thoracic impedance, respiration rate (RR), heart rate (HR), relative tidal volume (rTV), RR variability, HR variability, RR/rTV, QRS width, QTc width, presence of atrial fibrillation, and diastolic heart sound strength
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7 months
|
|
Patient Quality of Life
Time Frame: 6 months
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Patient quality of live measured through the Minnesota Living with Heart Failure questionnaire.
The questionnaire measures how heart failure impacts the patient's life scale is 0-5.
0 is does not apply, 1 is very little and 5 is very much.
Higher scores indicate a worse quality of life.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Compliance rates
Time Frame: 6 months
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Percent of days with at least one measurement
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6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TUFTS-PILOT-1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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