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

NCT03416920 | Completed Results

• 1 other identifier: 2017P002582
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 2

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.

Conditions

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Readmission at 30 Days

  How many subjects were readmitted to the hospital

  30 Days

Secondary Outcomes (2)

• Number of Participants With Readmission at 90 Days

  90 Days

• Number of Participants Enrolled in Clinic-based Cardiac Rehab at 90 Days

  90 days

Study Arms (1)

Wellframe

EXPERIMENTAL

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

Other: Wellframe

Interventions

Wellframe OTHER

Wellframe mobile phone app

Wellframe

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking PCI: balloon angioplasty, bare-metal stent, or drug-eluting stent at MGH Smartphone or Tablet (iOS or Android)

You may not qualify if:

• Recent (within 1mo) illicit substance use or alcohol abuse In-hospital AMI Known pregnancy Dementia or cognitive disability Incarceration

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Boston Scientific Corporation: collaborator
• Wellframe, Inc.: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02114, United States

Location

Massachusetss General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 34657825 DERIVED

Results Point of Contact

• Title: Dr. Pradeep Natarajan
• Organization: Massachusetts General Hospital

PNATARAJAN@PARTNERS.ORG

617-724-3526

Study Officials

• Pradeep Natarajan, MD, MMSc

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Preventative Cardiology

Model Details: Enroll and onboard 150 patients with the Wellframe application

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: January 31, 2018
• Study Start: February 12, 2018
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: July 17, 2023
• Results First Posted: July 17, 2023

Record last verified: 2022-08

Locations

US (2)