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

Not Applicable

Completed

• Conditions: Percutaneous Coronary Intervention
• Interventions: Other: Wellframe

• Registration Number: NCT03416920
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Study Start: 2018-02-12
• Primary Completion: 2019-08-20
• Study Completion: 2019-08-20
• Results First Submitted: 2021-09-02
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-25
• Last Update Submitted: 2022-08-25
• Results First Posted: 2023-07-17
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Readmission at 30 Days	30 Days	How many subjects were readmitted to the hospital

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Readmission at 90 Days	90 Days	How many subjects were readmitted to the hospital
Number of Participants Enrolled in Clinic-based Cardiac Rehab at 90 Days	90 days	Percent of patients discharged after intervention who attend at least one session of clinic-based cardiac rehab

Trial Locations

Locations (2)

Massachusetss General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States