Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05980585
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-07-26
Brief Title:
Assessment of Heart Failure HF At-Home Management Solution ADI Cardio Pulmonary Monitoring System CPM
Sponsor:
Analog Device Inc
Organization:
Analog Device Inc
Study Overview
Official Title:
Assessment of Heart Failure HF At-Home Management Solution ADI Cardio Pulmonary Monitoring System CPM
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 baselineinitial 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 ie 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 linescomet 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
The duration of the study for each patient will be approximately 60 days beginning with the baselineinitial 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 ie 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 linescomet 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None