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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03416920
• Collaborator: Boston Scientific Corporation (Industry), Wellframe, Inc (Other)
• Enrollment: 118
• Locations: 2
• Arm: 1
• Actual Duration (Months): 18.2
• Patients Per Site: 59
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Enroll and onboard 150 patients with the Wellframe applicationEnroll 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: Feb 12, 2018
• Actual Primary Completion Date: Aug 20, 2019
• Actual Study Completion Date: Aug 20, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Readmission Rate 30 day [30 Days]

   How many subjects were readmitted to the hospital

Secondary Outcome Measures

1. Readmission Rate 90 day [90 Days]

   How many subjects were readmitted to the hospital

2. Enrollment in clinic-based cardiac rehab [90 days]

   Percent of patients discharged after intervention who attend at least one session of clinic-based cardiac rehab

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02114
2	Massachusetss General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• Boston Scientific Corporation
• Wellframe, Inc

Investigators

• Principal Investigator: Pradeep Natarajan, MD, MMSc, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pradeep Natarajan, Director of Preventative Cardiology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03416920
• Other Study ID Numbers: 2017P002582
• First Posted: Jan 31, 2018
• Last Update Posted: Feb 19, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Infarction

Study Results

No Results Posted as of Feb 19, 2020