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A Smartphone-based Application Post-myocardial Infarction to Manage Cardiovascular Disease Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416920
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : February 19, 2020
Sponsor:
Collaborators:
Boston Scientific Corporation
Wellframe, Inc
Information provided by (Responsible Party):
Pradeep Natarajan, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Other: Wellframe Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Enroll and onboard 150 patients with the Wellframe application
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Smartphone-based Application Post-myocardial Infarction to Manage Cardiovascular Disease Risk
Actual Study Start Date : February 12, 2018
Actual Primary Completion Date : August 20, 2019
Actual Study Completion Date : August 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Wellframe
Subjects in this arm will use the Wellframe application for 90 days
Other: Wellframe
Wellframe mobile phone app




Primary Outcome Measures :
  1. Readmission Rate 30 day [ Time Frame: 30 Days ]
    How many subjects were readmitted to the hospital


Secondary Outcome Measures :
  1. Readmission Rate 90 day [ Time Frame: 90 Days ]
    How many subjects were readmitted to the hospital

  2. Enrollment in clinic-based cardiac rehab [ Time Frame: 90 days ]
    Percent of patients discharged after intervention who attend at least one session of clinic-based cardiac rehab



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416920


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02114
Massachusetss General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Boston Scientific Corporation
Wellframe, Inc
Investigators
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Principal Investigator: Pradeep Natarajan, MD, MMSc Massachusetts General Hospital
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Responsible Party: Pradeep Natarajan, Director of Preventative Cardiology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03416920    
Other Study ID Numbers: 2017P002582
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases