Atrial FibrillationNCT04599114
Virtual for Care Atrial Fibrillation Patients Using VIRTUES
A study testing VIRTUES in people with Atrial Fibrillation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 3 sites in Canada.
Trial summary
Patients will atrial fibrillation, a type of irregular heart rhythm, frequently go to the emergency room in order to manage their condition. This study will use a chart review to look at the characteristics and frequency of atrial fibrillation patients who go to the emergency room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- VIRTUES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Nov 2020to 1 Nov 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to provide informed consent
- documented symptomatic new-onset or pre-existing, non-valvular AF
- ER visit or hospitalization for primary AF in the last 6 months
- proficient in the English language
Who cannot join
- unable to provide informed consent
- planning to move/relocate during the period of study
- current pregnancy
- patient is a prisoner/incarcerated
- no access to a smart device with Bluetooth capabilities
- planned percutaneous coronary intervention, coronary artery bypass graphing or heart valve surgery within the next year
- any medical condition making 1 year survival unlikely
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Ratika Parkash, MD, 902-473-2700
Ratika Parkash, MD
Rachel Caris
London, Ontario, N6A 5A5
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Dana Murray, BScN, 416-480-6100 ext. 1994
Benedict Glover, MD
About this study
Official title: Virtual for Care Atrial Fibrillation Patients Using VIRTUES (Virtual Integrated Reliable Transformative User-Driven E-Health System)
Patients will atrial fibrillation, a type of irregular heart rhythm, frequently go to the emergency room in order to manage their condition. This study will use a chart review to look at the characteristics and frequency of atrial fibrillation patients who go to the emergency room. In addition to the chart review, patients with atrial fibrillation who have recently gone to the emergency room or have been hospitalized will be approached and asked if they want to use an electronic health care system that can be accessed by both themselves and their health care providers. Along with the system, patients will be given a Health Canada approved heart rhythm sensor, so patients will be able to record their heart rhythm when they feel symptoms and send the information to the heart rhythm team. The heart rhythm team will then make real-time recommendations to the patient about how they can manage their rhythm and symptoms. Patients will be asked to complete satisfaction and quality of life surveys. Our goal is to provide efficient and effective care for patients with AF, resulting in decreased repeat ED visits.
Read the detailed description
See brief summary.
- Conditions
- Atrial Fibrillation
- Being tested
- VIRTUES
- Keywords
- Virtual care
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIRTUESBehavioural
VIRTUES is a digital health platform that offers 2 way communication between clinicians and patients to address symptoms stemming from atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| VIRTUES Arm | Experimental | Patients in the VIRTUES arm will be offered enrollment into the virtual atrial fibrillation care platform. Receives: Behavioral: VIRTUES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who present to the emergency department due to atrial fibrillation, after their index visit
See title
Measured: 12 months
Secondary outcomes (6)
Number of AF-related ER visit per patient, post index visit
See title
Measured: 12 months
Utility of the system
Number of uses of the system/patient, number of accesses to the health record, number of heart rhythm VIRTUES team - patient feedbacks on the VIRTUES app, percentage of care plans followed by the patient
Measured: 12 months
Survey-based experience with the VIRTUES application
Survey-based experience will be determined by the "Virtual AF Care Patient Satisfaction Questionnaire". The questionnaire consists of 5 questions regarding the VIRTUES platform using a 5 point likert scale (strongly agree to strongly disagree) in addition to a final open ended question asking for feedback regarding the application.
Measured: Baseline, 3 months, 12 months
Pre and post patient reported outcomes using the Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaire and the EQ-5D-5L
The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire is a well-validated questionnaire with 2 sections. The first section asked about a patient's incidence of atrial fibrillation, the second section inquires as to the presence of atrial fibrillation symptomsand how limiting they were. In general, higher scores mean more frequent atrial fibrillation symptoms that are very/extremely limiting and bothersome.
Measured: Baseline, 3 months, 12 months
Time to stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death
The length of time between index presentation for atrial fibrillation and the onset of any of the above conditions will be calculated for both the retrospective and prospective cohorts.
Measured: 12 months
Frequency of stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death
The number of any of the above conditions occurring in both the retrospective and prospective cohorts will be counted and analyzed.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2024 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will use a retrospective chart review to examine characteristics of patients who present to the emergency room with atrial fibrillation as well as a non-randomized prospective cohort who will be offered enrollment into the virtual platform.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada
- Responsible party
- Principal investigator, Allan Skanes, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Allan C Skanes, Md, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599114
- Sponsor's protocol ID
- 4411
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2020
- Last updated
- 22 Oct 2020
- 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual for Care Atrial Fibrillation Patients Using VIRTUES (Virtual Integrated Reliable Transformative User-Driven E-Health System)
- ClinicalTrials.gov ID
- NCT04599114
- Acronym / sponsor ID
- 4411
- Conditions
- Atrial Fibrillation
- Keywords
- Virtual care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 22 Oct 2020 (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.
Patients will atrial fibrillation, a type of irregular heart rhythm, frequently go to the emergency room in order to manage their condition. This study will use a chart review to look at the characteristics and frequency of atrial fibrillation patients who go to the emergency room. In addition to the chart review, patients with atrial fibrillation who have recently gone to the emergency room or have been hospitalized will be approached and asked if they want to use an electronic health care system that can be accessed by both themselves and their health care providers. Along with the system, patients will be given a Health Canada approved heart rhythm sensor, so patients will be able to record their heart rhythm when they feel symptoms and send the information to the heart rhythm team. The heart rhythm team will then make real-time recommendations to the patient about how they can manage their rhythm and symptoms. Patients will be asked to complete satisfaction and quality of life surveys. Our goal is to provide efficient and effective care for patients with AF, resulting in decreased repeat ED visits.
Detailed description
See brief summary.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will use a retrospective chart review to examine characteristics of patients who present to the emergency room with atrial fibrillation as well as a non-randomized prospective cohort who will be offered enrollment into the virtual platform.
| Arm | Type | Receives |
|---|---|---|
| VIRTUES Arm | Experimental | Behavioral: VIRTUESPatients in the VIRTUES arm will be offered enrollment into the virtual atrial fibrillation care platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- able to provide informed consent
- documented symptomatic new-onset or pre-existing, non-valvular AF
- ER visit or hospitalization for primary AF in the last 6 months
- proficient in the English language
Key exclusion criteria (7 listed)
- unable to provide informed consent
- planning to move/relocate during the period of study
- current pregnancy
- patient is a prisoner/incarcerated
- no access to a smart device with Bluetooth capabilities
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 |
|---|---|---|
| VIRTUESVIRTUES is a digital health platform that offers 2 way communication between clinicians and patients to address symptoms stemming from atrial fibrillation. | Behavioural | VIRTUES Arm |
Primary outcome
Number of patients who present to the emergency department due to atrial fibrillation, after their index visit
Time frame: 12 months
See title
6 secondary outcomes
Number of AF-related ER visit per patient, post index visit
Time frame: 12 months
Utility of the system
Time frame: 12 months
Survey-based experience with the VIRTUES application
Time frame: Baseline, 3 months, 12 months
Pre and post patient reported outcomes using the Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaire and the EQ-5D-5L
Time frame: Baseline, 3 months, 12 months
Time to stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death
Time frame: 12 months
Frequency of stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- 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.
Allan C Skanes, Md principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIRTUES in people with Atrial Fibrillation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 3 sites in Canada.
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 4 inclusion and 7 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 Rachel A Caris, BScN (5196858500 ext. 32835, rachel.caris@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who present to the emergency department due to atrial fibrillation, after their index visit (time frame: 12 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 22 Oct 2020.