CHFNCT03207802
Remotely Monitoring Patients With Chronic Conditions in Their Home
An observational study of CHF, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health. Read more about this study
- Who is it for?
- Ages 22 to 99 years
- Conditions the study is for
- CHF
- What is being tested?
- Discontinuation of using device
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2017to 20 Dec 2017
- 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 22 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving home health care with one or more chronic diseases including CHF
Who may be able to join
- Chronic Disease including CHF
- Currently receiving home health care
- Recent discharge for a CHF event
Who cannot join
- Skin reaction to electrodes
- Inability to take measurements due to low BMI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Necklace-Shaped Sensor for Non-Invasive Measurement of Vital Signs, Thoracic Impedance, ECG, Skin Temperature and Motion
Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health.
Read the detailed description
Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health. Data from the CoVa Monitoring System will be compared against electronic health records to determine if the data captured will provide insight into a patient's overall health. Additionally, user compliance will be monitored
- Conditions
- CHF
- Being tested
- Discontinuation of using device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of using deviceDevice
Subject will be instructed to discontinuation of use of device
| Study group | Role | What they receive |
|---|---|---|
| Cohort 3 | This cohort is living at home with a chronic condition. Receives: Device: Discontinuation of using device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data correlation
Correlation between data collection and potential heart failure event
Measured: 2-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start21 Jun 2017
- Primary completion17 Dec 2017
- Study completion20 Dec 2017
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
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207802
- Sponsor's protocol ID
- PERM-IRB-001-OCS
- Status last verified
- Jan 2018
- First submitted
- 30 Jun 2017
- Last updated
- 10 Sep 2019
- 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 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necklace-Shaped Sensor for Non-Invasive Measurement of Vital Signs, Thoracic Impedance, ECG, Skin Temperature and Motion
- ClinicalTrials.gov ID
- NCT03207802
- Acronym / sponsor ID
- PERM-IRB-001-OCS
- Conditions
- CHF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 17 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 5 Jul 2017 (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.
Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health.
Detailed description
Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health. Data from the CoVa Monitoring System will be compared against electronic health records to determine if the data captured will provide insight into a patient's overall health. Additionally, user compliance will be monitored
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 3 | – | Device: Discontinuation of using deviceThis cohort is living at home with a chronic condition. |
Who may qualify
- Ages
- 22 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving home health care with one or more chronic diseases including CHF
Key inclusion criteria (3 listed)
- Chronic Disease including CHF
- Currently receiving home health care
- Recent discharge for a CHF event
Key exclusion criteria (2 listed)
- Skin reaction to electrodes
- Inability to take measurements due to low BMI
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 |
|---|---|---|
| Discontinuation of using deviceSubject will be instructed to discontinuation of use of device | Device | Cohort 3 |
Primary outcome
Data correlation
Time frame: 2-6 months
Correlation between data collection and potential heart failure event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Baxter Healthcare Corporation 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 10 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data correlation (time frame: 2-6 months). 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 10 Sep 2019.