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

NCT ID: NCT03416920

Last Updated: 2023-07-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2019-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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Percutaneous Coronary Intervention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Enroll and onboard 150 patients with the Wellframe application
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Wellframe

Subjects in this arm will use the Wellframe application for 90 days

Group Type EXPERIMENTAL

Wellframe

Intervention Type OTHER

Wellframe mobile phone app

Interventions

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Wellframe

Wellframe mobile phone app

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Wellframe, Inc.

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pradeep Natarajan

Director of Preventative Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pradeep Natarajan, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Massachusetss General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34657825 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017P002582

Identifier Type: -

Identifier Source: org_study_id

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