Heart FailureNCT02343523
Pilot Study of the QI Device for Monitoring of Patients With Congestive Heart Failure
An observational study of Heart Failure, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
The present study proposes to utilize a novel, wearable device, QI Device, which has multiple sensors embedded in a "wrist-watch" in order to explore its monitoring capabilities in individuals with congestive heart failure. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Sep 2015
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population in both phases of the study will be made up of adult men and women admitted to the hospital with a clinical diagnosis of acute decompensated heart failure. Phase 1 and Phase 2 will include up to 10 individuals each that meet the following Inclusion criteria and have no Exclusion criteria.
Who may be able to join
- Adults over age 18
- Own, and comfortable using, a home computer with internet access (Phase 2 only)
- Acute hospitalization with a primary diagnosis of acute decompensated heart failure (ADHF) diagnosed on the basis of all of the following:
- Symptoms:
- Onset or worsening of dyspnea within the past 2 weeks
- Physical exam (at least 1 present):
Show all 13Show fewer
- Rales/ Crackles on auscultation
- Elevated JVP > 10 cmH2O
- Weight gain
- LE edema
- Diagnostic imaging/ labs (at least 1 present):
- Evidence of pulmonary congestion or edema on chest X-ray/ chest CT
- Elevated BNP or NT-pro-BNP (age-adjusted)
Who cannot join
- Psychological or social situation that would make the study difficult for the patient
- Inability to consent
- Chronic atrial fibrillation or other dysrhythmia with a high (>10%) burden of ectopic beats.
- Pregnant women
- Pneumonia - currently, or within the past 30 days
- Non-cardiogenic pulmonary edema (e.g. ARDS)
- Interstitial lung disease
- End-stage renal disease and on Hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Quanttus Device for Monitoring of Patients With Congestive Heart Failure
The present study proposes to utilize a novel, wearable device, QI Device, which has multiple sensors embedded in a "wrist-watch" in order to explore its monitoring capabilities in individuals with congestive heart failure.
Read the detailed description
The QI Device is a self-contained, reusable, rechargeable, battery-powered, wrist-watch that simultaneously tracks and records a number of physiological health related parameters such as heart rate, blood pressure, respiratory rate, temperature, and motion/position. One advantage of this device over current home diagnostic systems is the capability for longitudinal monitoring.
- Conditions
- Heart Failure
- Keywords
- Wearable device, Wrist-watch, Longitudinal monitoring, Congestive Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
To capture continuous vital signs via a wrist-based wearable physiologic monitor among patients with acute decompensated heart failure (ADHF) in 2 phases
Phase 1: Will include hospitalized patients admitted to the hospital with a clinical diagnosis of ADHF. Phase 2: Will include patients being discharged from the hospital with a primary clinical diagnosis of ADHF and will be monitored for up to 30 days following hospitalization.
Measured: ~7to 30 days
Secondary outcomes (1)
To explore the development of predictive algorithms to allow for the early identification of patients at risk of acute decompensation and/or HF hospitalization.
Measured: ~40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Steinhubl, Scripps Translational Science Institute
- Investigators
- Steven Steinhuble, MD, Principal investigator, STSIAjay Srivastava, MD, Principal investigator, STSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343523
- Sponsor's protocol ID
- 14-6510
- Status last verified
- May 2016
- First submitted
- 18 Dec 2014
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Quanttus Device for Monitoring of Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT02343523
- Acronym / sponsor ID
- 14-6510
- Conditions
- Heart Failure
- Keywords
- Wearable device, Wrist-watch, Longitudinal monitoring, Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Jan 2015 (estimated)
- 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.
The present study proposes to utilize a novel, wearable device, QI Device, which has multiple sensors embedded in a "wrist-watch" in order to explore its monitoring capabilities in individuals with congestive heart failure.
Detailed description
The QI Device is a self-contained, reusable, rechargeable, battery-powered, wrist-watch that simultaneously tracks and records a number of physiological health related parameters such as heart rate, blood pressure, respiratory rate, temperature, and motion/position. One advantage of this device over current home diagnostic systems is the capability for longitudinal monitoring.
Study design
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population in both phases of the study will be made up of adult men and women admitted to the hospital with a clinical diagnosis of acute decompensated heart failure. Phase 1 and Phase 2 will include up to 10 individuals each that meet the following Inclusion criteria and have no Exclusion criteria.
Key inclusion criteria (13 listed)
- Adults over age 18
- Own, and comfortable using, a home computer with internet access (Phase 2 only)
- Acute hospitalization with a primary diagnosis of acute decompensated heart failure (ADHF) diagnosed on the basis of all of the following:
Key exclusion criteria (8 listed)
- Psychological or social situation that would make the study difficult for the patient
- Inability to consent
- Chronic atrial fibrillation or other dysrhythmia with a high (>10%) burden of ectopic beats.
- Pregnant women
- Pneumonia - currently, or within the past 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To capture continuous vital signs via a wrist-based wearable physiologic monitor among patients with acute decompensated heart failure (ADHF) in 2 phases
Time frame: ~7to 30 days
Phase 1: Will include hospitalized patients admitted to the hospital with a clinical diagnosis of ADHF. Phase 2: Will include patients being discharged from the hospital with a primary clinical diagnosis of ADHF and will be monitored for up to 30 days following hospitalization.
1 secondary outcome
To explore the development of predictive algorithms to allow for the early identification of patients at risk of acute decompensation and/or HF hospitalization.
Time frame: ~40 days
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 5 May 2016.
- 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.
Steven Steinhuble, MD principal investigator
STSI
Ajay Srivastava, MD principal investigator
STSI
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 Heart Failure, run by Scripps Translational Science Institute 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 13 inclusion and 8 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 5 May 2016. 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?
To capture continuous vital signs via a wrist-based wearable physiologic monitor among patients with acute decompensated heart failure (ADHF) in 2 phases (time frame: ~7to 30 days). 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 5 May 2016.