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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
| Wellframe, Inc. | INDUSTRY |
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The investigators aim to evaluate Wellframe, a patient engagement platform that includes a mobile phone application for patients, for its impact on supporting patients who have undergone a percutaneous coronary intervention. The patient mobile app has articles about cardiovascular disease and other health related topics, patient-reported outcomes surveys, physical activity tracking, reminders for medications and upcoming appointments, and two-way communication with a Wellframe Health Advocate. The Wellframe Health Advocate encourages patients to achieve their health goals and stay engaged in their health. The feasibility of onboarding patients to the app and the clinical efficacy of the platform will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wellframe | Experimental | Subjects in this arm will use the Wellframe application for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wellframe | Other | Wellframe mobile phone app |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Readmission at 30 Days | How many subjects were readmitted to the hospital | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Readmission at 90 Days | How many subjects were readmitted to the hospital | 90 Days |
| Number of Participants Enrolled in Clinic-based Cardiac Rehab at 90 Days | Percent of patients discharged after intervention who attend at least one session of clinic-based cardiac rehab |
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Inclusion Criteria:
English-speaking PCI: balloon angioplasty, bare-metal stent, or drug-eluting stent at MGH Smartphone or Tablet (iOS or Android)
Exclusion Criteria:
Recent (within 1mo) illicit substance use or alcohol abuse In-hospital AMI Known pregnancy Dementia or cognitive disability Incarceration
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| Name | Affiliation | Role |
|---|---|---|
| Pradeep Natarajan, MD, MMSc | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02114 | United States | ||
| Massachusetss General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34657825 | Derived | Paruchuri K, Finneran P, Marston NA, Healy EW, Andreo J Jr, Lynch R, Blood AJ, Jones-O'Connor M, Lander B, Kelly N, Vivaldi MT, Traynor K, Wiviott S, Natarajan P. Outcomes of a smartphone-based application with live health-coaching post-percutaneous coronary intervention. EBioMedicine. 2021 Oct;72:103593. doi: 10.1016/j.ebiom.2021.103593. Epub 2021 Oct 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Wellframe | Subjects in this arm will use the Wellframe application for 90 days Wellframe: Wellframe mobile phone app |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Wellframe | Subjects in this arm will use the Wellframe application for 90 days Wellframe: Wellframe mobile phone app |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Readmission at 30 Days | How many subjects were readmitted to the hospital | Posted | Count of Participants | Participants | 30 Days |
|
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During the study period, 90 days from enrollment.
The number of participants at risk for Other Adverse Events is zero because the study is minimal risk. Since the study involves adding a mobile health component to a treatment plan, risks posed to subjects are similar to those involved with following a post-PCI care plan.
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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 | Wellframe | Subjects in this arm will use the Wellframe application for 90 days Wellframe: Wellframe mobile phone app |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pradeep Natarajan | Massachusetts General Hospital | 617-724-3526 | PNATARAJAN@PARTNERS.ORG |
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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 | Feb 26, 2019 | Sep 1, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 28, 2019 | Sep 1, 2021 | SAP_001.pdf |
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Enroll and onboard 150 patients with the Wellframe application
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| 90 days |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Number of Participants With Readmission at 90 Days | How many subjects were readmitted to the hospital | Posted | Count of Participants | Participants | 90 Days |
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| Secondary | Number of Participants Enrolled in Clinic-based Cardiac Rehab at 90 Days | Percent of patients discharged after intervention who attend at least one session of clinic-based cardiac rehab | Posted | Count of Participants | Participants | 90 days |
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| 0 |
| 118 |
| 0 |
| 118 |
| 0 |
| 118 |
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