Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05980585 |
Other study ID # |
OBS-BAPTISTJAX |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 20, 2022 |
Est. completion date |
June 1, 2025 |
Study information
Verified date |
February 2024 |
Source |
Analog Device, Inc. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study is meant primarily to assess the deployment of the ADI CPM System in a clinical
setting and determine interoperability of the CPM System within existing care pathways for
patients with CHF. In this initial study the CPM System will not be used to determine or
support clinical decision making however post deployment the clinical study team will review
patient HF events and changes in treatment during the course of the deployment and compare to
the data generated by the CPM System during the study to determine the accuracy of the
patient generated data as a basis for designing a more comprehensive "interventional study"
to determine clinical and financial efficacy of the CPM System.
Description:
Patients will be recruited and begin the study as they are identified and consent to the
study. Recruiting will end either by a designated date set at the initiation of the study or
when 30 patients have been enrolled in the study.
The duration of the study for each patient will be approximately 60 days beginning with the
baseline/initial visit and concluding 30 days after the patient has completed device use. The
patient will use the device given to the once a day during the first 60 days the study and
following that time patient records will be reviewed retrospectively for CHF events for the
60 days plus an additional 30 days after their last measurement. Each patient will also
receive weekly calls from the research team to check in on device functionality and assure
adherence to the protocol.
At visit 1, the start of the study, baseline information will be collected, importantly
including accurate weight and notes about congestion and fluid buildup. The study will be
re-described to the participant. The research team will then set up the device for the
individual patient by making adjustments (as needed) to address patient specific anatomy),
ensuring that the sensors are all contacting the appropriate chest areas, and confirming the
measurements on the CPM Web application. The patient will be shown how to apply and replace
the adhesive on the device, how to position the device, how to take a measurement with the
device, and how to store the device on the Base Station. The trained provider will then
register the baseline reading for the CHF device using the CHF Mobile App.
Informational materials about using the device, refreshing adhesives, and meanings of LEDs
and chimes on the device will also be given to the patient. The patient will be instructed to
follow the normal regimen prescribed by their by their physician, but to add taking a
measurement with their CPM at the same time each day (preferably when they first wake up).
Between visits, caregivers will not have any access to the data being collected on the CHF
Device. They should perform their usual standard of care on these patients. Participants will
also receive calls from the research team to check in about the progress of the study (i.e.,
if protocols are being followed correctly, if the CPM device is working properly, and if
adherence is satisfactory. This check-in, conversation topics should focus on any ease-of-use
issues and address any compliance-based issues.
The ADI team will have access to data (without any patient identifying information)
throughout the course of the trial, including adherence rates of patients. The sponsors will
reach out to the study team if a specific patient is found to have missed 2 days in a row of
measurements. The research team will contact patients directly if there is a continued trend
towards non-compliance.
If a participant is having technical difficulties using the CPM System, the research team in
conjunction with ADI will provide direct (in office) or remote assistance or replace existing
equipment as necessary.
On visit 2, which will take place at the end of the 60 days, the research team will make
arrangements for the patient to return to the office for a check-up and return the device
(the same tests as described in the "physical examination" section including b lines/comet
tails, dyspnea scale, etc.). Patients will also be asked about their perception on "ease of
use", impact on day-to-day activities, and overall satisfaction with the CPM system. Thirty
days following the last measurement the study team, will review the patients records for all
HF related events and treatment changes.