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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afib 2gether TM Mobile Application | Device | The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Placed on Anticoagulation After Cardiology Appointment | This outcome measures the number of patient participants with a CHA2DS2-VASc stroke scale score of 2 or higher who are placed on anticoagulation therapy following cardiology appointment. Patients switch to AC will be monitored via the electronic health record. The CHA2DS2-VASc scale is an evaluation of stroke risk for patients with atrial fibrillation. The scale is a composite of 7 questions, with an overall scale score of 0 to 9, with low scores indicating low risk for stroke, and high scores indicating high risk for stroke. |
Inclusion Criteria:
Providers:
Patients:
Exclusion Criteria:
Providers:
Patients:
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| Name | Affiliation | Role |
|---|---|---|
| Alok Kapoor, MD | UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Medical School | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34806997 | Derived | 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. | |
| 33625361 | Derived | Kapoor 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. |
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We identified 40 patients seeing 13 cardiology providers. Of the 40 patients, 2 were later found ineligible and 1 patient was disenrolled due to provider preference leaving us with 37 patient encounters to analyze. Of the 13 providers, 10 completed the accuracy assessment.
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| ID | Title | Description |
|---|---|---|
| FG000 | AFib 2gether(TM) App | 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. Afib 2gether TM Mobile Application: The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app. |
| FG001 | Providers | Providers caring for the patients with known Atrial Fibrillation will be asked to review the patients' stroke risk score on the AFib 2gether app and compare to their clinical assessment for accuracy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Information about patient characteristics (such as demographics) was collected in addition to the patients stroke risk score and reason why they were not on an anticoagulant (AC) prior to their appointment in the cardiology clinic. Baseline data for providers such as provider characteristics was not collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | AFib 2gether(TM) App | 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. Afib 2gether TM Mobile Application: The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | The patients age was collected through the Electronic Medical record (EHR). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients with a stroke risk score of 2 or higher and have a diagnosis of AF. | Posted | Mean | Standard Deviation | score on a scale | Immediately after visit |
|
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The proposed study involves no more than minimal risk to participants but adverse events can be self reported by participants for the duration of the study, 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AFib 2gether(TM) App | 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. Afib 2gether TM Mobile Application: The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alok Kapoor | University of Massachusetts Medical School | 917-856-4538 | alok.kapoor@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 3, 2020 | Aug 10, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2020 | Feb 1, 2022 | SAP_002.pdf |
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| 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. | 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. | Immediately after visit. |
| up to 6 months |
| BG001 | Providers | Providers caring for the patients with known Atrial Fibrillation will be asked to review the patients' stroke risk score on the AFib 2gether app and compare to their clinical assessment for accuracy. Baseline measures were not collected for providers. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Stroke Risk Score | The CHA2DS2-VASc scale is an evaluation of stroke risk in patients with atrial fibrillation. The scale is a composite of 7 questions (based on age, sex, congestive heart failure history, hypertension history, stroke/transient ischemic attack/thromboembolism history, vascular disease history, diabetes history), with an overall scale score of 0 to 9, with low scores indicating low risk for stroke, and high scores indicating high risk for stroke. | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | 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. | Providers are considered to be enrolled in the study. | Posted | Mean | Standard Deviation | units on a scale | Immediately after visit. |
|
|
|
| Secondary | 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. | Posted | Number | participants | Immediately after visit |
|
|
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| Other Pre-specified | Number of Patients Placed on Anticoagulation After Cardiology Appointment | This outcome measures the number of patient participants with a CHA2DS2-VASc stroke scale score of 2 or higher who are placed on anticoagulation therapy following cardiology appointment. Patients switch to AC will be monitored via the electronic health record. The CHA2DS2-VASc scale is an evaluation of stroke risk for patients with atrial fibrillation. The scale is a composite of 7 questions, with an overall scale score of 0 to 9, with low scores indicating low risk for stroke, and high scores indicating high risk for stroke. | Patients with AF with a stroke risk score that is 2 or higher. | Posted | Count of Participants | Participants | up to 6 months |
|
|
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| Secondary | 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. | Providers are considered enrolled in the study. | Posted | Number | accurate scores | Immediately after visit. |
|
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| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Providers | Providers caring for the patients with known Atrial Fibrillation will be asked to review the patients' stroke risk score on the AFib 2gether app and compare to their clinical assessment for accuracy. | 0 | 13 | 0 | 13 | 0 | 13 |
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| Title | Measurements |
|---|---|
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| Fall Risk |
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| GI Bleed |
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| Other Bleed |
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