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NCT03416920 Clinical Trial

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

Percutaneous Coronary Intervention Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03416920
Other study ID # 2017P002582
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 12, 2018
Est. completion date August 20, 2019

Study information
Verified date August 2022
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 167
Est. completion date August 20, 2019
Est. primary completion date August 20, 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Wellframe
Wellframe mobile phone app

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetss General Hospital Boston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
Massachusetts General Hospital Boston Scientific Corporation, Wellframe, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Readmission at 30 Days How many subjects were readmitted to the hospital 30 Days
Secondary Number of Participants With Readmission at 90 Days How many subjects were readmitted to the hospital 90 Days
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 90 days
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