CHFNCT05865197
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF
An observational study of CHF and Congestive Heart Failure, run by Sensorum Health Inc. at 1 site in United States.
Trial summary
Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- CHF, Congestive Heart Failure
- What is being tested?
- Data collection
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2022to 1 Sep 2024
- Phase
- Observational
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Current Patient of PI's clinic at Weill Cornell Medicine
Who may be able to join
- Current Patient at Weill Cornell Medicine
- Aged 55 years or older
- Able to consent
- Documented diagnosis of congestive heart failure (CHF)
- At least 1 of the following prior hospital utilization events in the past 12 months
- Inpatient admission for any reason
- Facility observation stay for any reason
- Emergency Department visit for any reason
Who cannot join
- Significant cardiac valvular disease
- End-Stage Renal Disease (ESRD)
- End-Stage CHF
- End-Stage COPD
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Kate Zarzuela, 646-962-5909, kaz4004@med.cornell.edu
About this study
Official title: Feasibility of Home-based, Ambient Passive Sensor Technology to Provide Early Warning of Health Decompensation by Detecting Deviations in Activities of Daily Living (ADLs) of Elderly Subjects With Diagnosed Chronic Heart Failure
Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.
- Conditions
- CHF, Congestive Heart Failure
- Being tested
- Data collection
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection of clinically relevant signals using home-based sensor system
| Study group | Role | What they receive |
|---|---|---|
| Passive monitoring | No intervention Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall of AI in passive sensor system
Evaluation of AI ability to prospectively detect hospital utilization event
Measured: 6 months
Precision of AI in passive sensor system
Evaluation of AI ability to precisely predict hospital utilization event
Measured: 6 months
Secondary outcomes (2)
Recall of sensor data review by trained nurses
Evaluation of nurse ability to prospectively detect hospital utilization event
Measured: 6 months
Precision of sensor data review by trained nurses
Evaluation of nurse ability to precisely predict hospital utilization event
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start28 Nov 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHFStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sensorum Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Parag Goyal, M.D., MSc, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865197
- Sponsor's protocol ID
- Sensorum P-002
- Status last verified
- Jan 2024
- First submitted
- 9 May 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Home-based, Ambient Passive Sensor Technology to Provide Early Warning of Health Decompensation by Detecting Deviations in Activities of Daily Living (ADLs) of Elderly Subjects With Diagnosed Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05865197
- Acronym / sponsor ID
- Sensorum P-002
- Conditions
- CHF, Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sensorum Health Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 18 May 2023 (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.
Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Passive monitoring | – | Other: Data collectionNo intervention |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Current Patient of PI's clinic at Weill Cornell Medicine
Key inclusion criteria (8 listed)
- Current Patient at Weill Cornell Medicine
- Aged 55 years or older
- Able to consent
- Documented diagnosis of congestive heart failure (CHF)
- At least 1 of the following prior hospital utilization events in the past 12 months
Key exclusion criteria (4 listed)
- Significant cardiac valvular disease
- End-Stage Renal Disease (ESRD)
- End-Stage CHF
- End-Stage COPD
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 |
|---|---|---|
| Data collectionData collection of clinically relevant signals using home-based sensor system | Other | Passive monitoring |
Primary outcome
Recall of AI in passive sensor system
Time frame: 6 months
Evaluation of AI ability to prospectively detect hospital utilization event
Precision of AI in passive sensor system
Time frame: 6 months
Evaluation of AI ability to precisely predict hospital utilization event
2 secondary outcomes
Recall of sensor data review by trained nurses
Time frame: 6 months
Precision of sensor data review by trained nurses
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- 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.
Parag Goyal, M.D., MSc principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CHF and Congestive Heart Failure, run by Sensorum Health Inc. at 1 site in United States.
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 8 inclusion and 4 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 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Christine Fernandez ((973) 786-3573, christine@sensorum.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recall of AI in passive sensor system (time frame: 6 months). 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 16 Jan 2024.