Atrial FibrillationNCT03860246
Atrial Fibrillation Screening in Nursing Homes
An observational study of Atrial Fibrillation, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This study was designed to screen high risk patients in nursing homes for atrial fibrillation with intermittent electrocardiogram (ECG) recordings using a portable, smartphone-based, mobile ECG recording device (Kardia Mobile, AliveCor, Inc.). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Portable ECG monitor
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 1 Nov 2018
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: nursing home residents
Who may be able to join
- Nursing home residents with ≥2 of the following risk factors for atrial fibrillation:
- age ≥75 years
- female sex
- obstructive sleep apnea
- peripheral vascular disease
- diabetes mellitus
Show all 9Show fewer
- obesity (body mass index [BMI] >30 kg/m2)
- hypertension
- congestive heart failure
Who cannot join
- prior diagnosis of AF
- continuous rhythm monitoring over the past year
- pacemaker or implantable cardioverter defibrillator in situ
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Atrial Fibrillation in High-Risk Nursing Home Residents
This study was designed to screen high risk patients in nursing homes for atrial fibrillation with intermittent electrocardiogram (ECG) recordings using a portable, smartphone-based, mobile ECG recording device (Kardia Mobile, AliveCor, Inc.). The investigators hypothesized that screening patients with 2 or more risk factors for atrial fibrillation would yield a higher incidence of atrial fibrillation compared to prior studies.
Read the detailed description
This is a prospective study that enrolled 245 residents from 15 participating nursing homes with ≥2 risk factors for atrial fibrillation. All residents gave informed consent or had a legally appointed representative who could consent on their behalf. Exclusion criteria included residents with a prior diagnosis of atrial fibrillation, continuous rhythm monitoring over the past year, and pacemaker or implantable cardioverter defibrillator in situ.
Screening was performed using the smartphone-based, mobile ECG recording device. Thirty second rhythm recordings were obtained on each resident on four different occasions within a month. All tracings were reviewed by a cardiologist and, in the case of any uncertainty, the diagnosis of atrial fibrillation was confirmed by an electrophysiologist. When atrial fibrillation was detected in a resident (primary endpoint), no further rhythm recordings were performed and the resident's nursing facility was then notified of the diagnosis. Further evaluation and treatment were directed by the resident's primary care physician.
All data were stored on a secure encrypted server with password protection. The investigators used chi-square and t-test analyses to determine if there were significant differences in demographic variables or risk factors for atrial fibrillation between residents with and without atrial fibrillation. Logistic regression analysis determined if any combination of risk factors was predictive of a positive atrial fibrillation screen.
- Conditions
- Atrial Fibrillation
- Being tested
- Portable ECG monitor
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable ECG monitorDiagnostic test
Recording of ECG rhythm on a portable monitor (Kardia Mobile)
What is being measured
The primary outcome is the main question the study is designed to answer.
atrial fibrillation
number of participants with atrial fibrillation on any of four rhythm recordings
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Feb 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Curtis, State University of New York at Buffalo
- Investigators
- Anne B Curtis, MD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860246
- Sponsor's protocol ID
- STUDY00001737
- Status last verified
- Feb 2019
- First submitted
- 14 Feb 2019
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Atrial Fibrillation in High-Risk Nursing Home Residents
- ClinicalTrials.gov ID
- NCT03860246
- Acronym / sponsor ID
- STUDY00001737
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 1 Mar 2019 (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.
This study was designed to screen high risk patients in nursing homes for atrial fibrillation with intermittent electrocardiogram (ECG) recordings using a portable, smartphone-based, mobile ECG recording device (Kardia Mobile, AliveCor, Inc.). The investigators hypothesized that screening patients with 2 or more risk factors for atrial fibrillation would yield a higher incidence of atrial fibrillation compared to prior studies.
Detailed description
This is a prospective study that enrolled 245 residents from 15 participating nursing homes with ≥2 risk factors for atrial fibrillation. All residents gave informed consent or had a legally appointed representative who could consent on their behalf. Exclusion criteria included residents with a prior diagnosis of atrial fibrillation, continuous rhythm monitoring over the past year, and pacemaker or implantable cardioverter defibrillator in situ.
Screening was performed using the smartphone-based, mobile ECG recording device. Thirty second rhythm recordings were obtained on each resident on four different occasions within a month. All tracings were reviewed by a cardiologist and, in the case of any uncertainty, the diagnosis of atrial fibrillation was confirmed by an electrophysiologist. When atrial fibrillation was detected in a resident (primary endpoint), no further rhythm recordings were performed and the resident's nursing facility was then notified of the diagnosis. Further evaluation and treatment were directed by the resident's primary care physician.
All data were stored on a secure encrypted server with password protection. The investigators used chi-square and t-test analyses to determine if there were significant differences in demographic variables or risk factors for atrial fibrillation between residents with and without atrial fibrillation. Logistic regression analysis determined if any combination of risk factors was predictive of a positive atrial fibrillation screen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- nursing home residents
Key inclusion criteria (9 listed)
- age ≥75 years
- female sex
- obstructive sleep apnea
- peripheral vascular disease
- diabetes mellitus
Key exclusion criteria (3 listed)
- prior diagnosis of AF
- continuous rhythm monitoring over the past year
- pacemaker or implantable cardioverter defibrillator in situ
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 |
|---|---|---|
| Portable ECG monitorRecording of ECG rhythm on a portable monitor (Kardia Mobile) | Diagnostic test | – |
Primary outcome
atrial fibrillation
Time frame: 30 days
number of participants with atrial fibrillation on any of four rhythm recordings
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 4 Mar 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.
Anne B Curtis, MD principal investigator
University at Buffalo
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 Atrial Fibrillation, run by State University of New York at Buffalo 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 9 inclusion and 3 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 4 Mar 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?
atrial fibrillation (time frame: 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 4 Mar 2019.