Atrial Fibrillation New OnsetAFib 2getherNCT04118270
Shared Decision-Making: AFib 2gether Mobile App
A study testing Afib 2gether TM Mobile Application in people with Atrial Fibrillation New Onset, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Shared Decision-Making: AFib 2gether™ is a research study that focuses on a mobile application developed by Pfizer, Inc with consultation from Dr McManus' called AFib 2gether™. Through this app, patients can determine their risk of stroke due to atrial fibrillation and prioritize questions and concerns for discussion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- Afib 2gether TM Mobile Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 26 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Providers:
- Caring for at least 3 patients aged 18 years and older
- Have at least 3 patients with International Classification of Diseases tenth revision (ICD-10) diagnostic code consistent with atrial fibrillation (AF) or atrial flutter
- Have at least 3 patients with a CHA2DS2-VASc stroke risk score of 2 or more
- Have at least 3 patients who are not on anticoagulation
- Have at least 3 patients with upcoming appointments within the next 4 months
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- Patients:
- Age 18+
- Preferred language is English
- Atrial fibrillation diagnosis
- Chads vasc score 2 or higher
- Not on anticoagulants
- No watchman or atrial appendage closure
- Had an ambulatory care center (ACC) cardiology appointment in the past 12 months
- Future appointment in the next 4 months with the same provider
Who cannot join
- Providers:
- Providers who do not care for at least 3 patients aged 18 years and older
- Have patients that do not have an ICD-10 diagnostic code consistent with AF or atrial flutter
- Does not have patients with a CHA2DS2-VASc stroke risk score of 2 or more
- Their patients are on anticoagulation
- Their 3 patients do not have an upcoming visit within the next 4 months
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- Patients:
- Under the age of 18; patients
- No ICD-10 diagnostic code consistent with AF or atrial flutter
- Did not have a visit with a cardiovascular medicine specialist in the previous one year
- Patients with a CHA2DS2-VASc score less than 2
- Currently prescribed an anticoagulant
- No upcoming cardiology visit in the next 3 months
- Has a WATCHMAN device or left atrial appendage closure surgery
- On hospice or for whom life expectancy is less than six months and patients
- Bleeding episode or fall with injury in the last four weeks
- Does not speak English
- Prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Shared Decision-Making: Implementing the AFib 2getherTM Mobile App
Shared Decision-Making: AFib 2gether™ is a research study that focuses on a mobile application developed by Pfizer, Inc with consultation from Dr McManus' called AFib 2gether™. Through this app, patients can determine their risk of stroke due to atrial fibrillation and prioritize questions and concerns for discussion with their cardiology provider.
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- Afib 2gether TM Mobile Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afib 2gether TM Mobile ApplicationDevice
The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app.
| Study group | Role | What they receive |
|---|---|---|
| AFib 2gether(TM) App | Experimental | Patients with known Atrial Fibrillation will be assigned to download and use an app targeted at determining stroke risk and increasing knowledge of Atrial Fibrillation and stroke risk along with treatment options and will use this information to facilitate a discussion with their cardiovascular provider. Receives: Device: Afib 2gether TM Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient MARS Scores
Patients evaluated the perceived usefulness of the AFib 2gether mobile application by taking the Mobile App Rating Scale (MARS) questionnaire. This evaluated 3 domains: functionality, aesthetics, and a star-based question. These scores are rated 1-5 with 5 being the highest (best) score.
Measured: Immediately after visit
Secondary outcomes (3)
Provider MARS Scores
Providers were asked to navigate the app features and rate their overall opinion of the mobile app by answering questions using the Mobile App Rating Scale (MARS). This scale evaluates 3 domains: functionality, aesthetics, and a star-based rating question. These scores are rated 1-5 with 5 being the highest (best) score.
Measured: Immediately after visit.
Reason Why the Patient Was Not on AC Prior to Their Appointment
This was an evaluation of why the patient was not on an anticoagulant (AC) prior to their appointment.
Measured: Immediately after visit
Afib 2gether Accuracy Assessment
The provider was asked to review the patients stroke risk score on the AFib 2gether app and compare to provider clinical assessment for accuracy. The number of accurate scores were recorded. Ten of the original thirteen providers completed this assessment.
Measured: Immediately after visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Nov 2019
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation New OnsetStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Alok Kapoor, University of Massachusetts, Worcester
- Investigators
- Alok Kapoor, MD, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118270
- Sponsor's protocol ID
- H00018053
- Acronym
- AFib 2gether
- Status last verified
- Mar 2022
- First submitted
- 3 Oct 2019
- Last updated
- 2 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kapoor A, Hayes A, Patel J, Patel H, Andrade A, Mazor K, Possidente C, Nolen K, Hegeman-Dingle R, McManus D. Usability and Perceived Usefulness of the AFib 2gether Mobile App in a Clinical Setting: Single-Arm Intervention Study. JMIR Cardio. 2021 Nov 19;5(2):e27016. doi: 10.2196/27016.
PubMed 34806997Kapoor A, Andrade A, Hayes A, Mazor K, Possidente C, Nolen K, Hegeman-Dingle R, McManus D. Usability, Perceived Usefulness, and Shared Decision-Making Features of the AFib 2gether Mobile App: Protocol for a Single-Arm Intervention Study. JMIR Res Protoc. 2021 Feb 24;10(2):e21986. doi: 10.2196/21986.
PubMed 33625361
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision-Making: Implementing the AFib 2getherTM Mobile App
- ClinicalTrials.gov ID
- NCT04118270
- Acronym / sponsor ID
- AFib 2gether / H00018053
- Conditions
- Atrial Fibrillation New Onset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Posted 31 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shared Decision-Making: AFib 2gether™ is a research study that focuses on a mobile application developed by Pfizer, Inc with consultation from Dr McManus' called AFib 2gether™. Through this app, patients can determine their risk of stroke due to atrial fibrillation and prioritize questions and concerns for discussion with their cardiology provider.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AFib 2gether(TM) App | Experimental | Device: Afib 2gether TM Mobile ApplicationPatients with known Atrial Fibrillation will be assigned to download and use an app targeted at determining stroke risk and increasing knowledge of Atrial Fibrillation and stroke risk along with treatment options and will use this information to facilitate a discussion with their cardiovascular provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Caring for at least 3 patients aged 18 years and older
- Have at least 3 patients with International Classification of Diseases tenth revision (ICD-10) diagnostic code consistent with atrial fibrillation (AF) or atrial flutter
- Have at least 3 patients with a CHA2DS2-VASc stroke risk score of 2 or more
- Have at least 3 patients who are not on anticoagulation
- Have at least 3 patients with upcoming appointments within the next 4 months
Key exclusion criteria (18 listed)
- Providers who do not care for at least 3 patients aged 18 years and older
- Have patients that do not have an ICD-10 diagnostic code consistent with AF or atrial flutter
- Does not have patients with a CHA2DS2-VASc stroke risk score of 2 or more
- Their patients are on anticoagulation
- Their 3 patients do not have an upcoming visit within the next 4 months
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 |
|---|---|---|
| Afib 2gether TM Mobile ApplicationThe Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app. | Device | AFib 2gether(TM) App |
Primary outcome
Patient MARS Scores
Time frame: Immediately after visit
Patients evaluated the perceived usefulness of the AFib 2gether mobile application by taking the Mobile App Rating Scale (MARS) questionnaire. This evaluated 3 domains: functionality, aesthetics, and a star-based question. These scores are rated 1-5 with 5 being the highest (best) score.
3 secondary outcomes
Provider MARS Scores
Time frame: Immediately after visit.
Reason Why the Patient Was Not on AC Prior to Their Appointment
Time frame: Immediately after visit
Afib 2gether Accuracy Assessment
Time frame: Immediately after visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34806997Kapoor A, Hayes A, Patel J, Patel H, Andrade A, Mazor K, Possidente C, Nolen K, Hegeman-Dingle R, McManus D. Usability and Perceived Usefulness of the AFib 2gether Mobile App in a Clinical Setting: Single-Arm Intervention Study. JMIR Cardio. 2021 Nov 19;5(2):e27016. doi: 10.2196/27016.
- Derived from this study: PubMed 33625361Kapoor A, Andrade A, Hayes A, Mazor K, Possidente C, Nolen K, Hegeman-Dingle R, McManus D. Usability, Perceived Usefulness, and Shared Decision-Making Features of the AFib 2gether Mobile App: Protocol for a Single-Arm Intervention Study. JMIR Res Protoc. 2021 Feb 24;10(2):e21986. doi: 10.2196/21986.
- 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.
Alok Kapoor, MD principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Afib 2gether TM Mobile Application in people with Atrial Fibrillation New Onset, run by University of Massachusetts, Worcester 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 15 inclusion and 18 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 2 May 2022. 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?
Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient MARS Scores (time frame: Immediately after visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118270, which also lists 2 linked publications.
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 2 May 2022.