Back to resultsA Smartphone-based Application Post-myocardial Infarction to Manage Cardiovascular Disease Risk
Primary Purpose
Percutaneous Coronary Intervention
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wellframe
Sponsored by
About this trial
This is an interventional supportive care trial for Percutaneous Coronary Intervention
Eligibility Criteria
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
Sites / Locations
- Brigham and Women's Hospital
- Massachusetss General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wellframe
Arm Description
Subjects in this arm will use the Wellframe application for 90 days
Outcomes
Primary Outcome Measures
Number of Participants With Readmission at 30 Days
How many subjects were readmitted to the hospital
Secondary Outcome Measures
Number of Participants With Readmission at 90 Days
How many subjects were readmitted to the hospital
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
Full Information
NCT ID
NCT03416920
First Posted
January 24, 2018
Last Updated
August 25, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Boston Scientific Corporation, Wellframe, Inc
1. Study Identification
Unique Protocol Identification Number
NCT03416920
Brief Title
A Smartphone-based Application Post-myocardial Infarction to Manage Cardiovascular Disease Risk
Official Title
A Smartphone-based Application Post-myocardial Infarction to Manage Cardiovascular Disease Risk
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Boston Scientific Corporation, Wellframe, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Coronary Intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Enroll and onboard 150 patients with the Wellframe application
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wellframe
Arm Type
Experimental
Arm Description
Subjects in this arm will use the Wellframe application for 90 days
Intervention Type
Other
Intervention Name(s)
Wellframe
Intervention Description
Wellframe mobile phone app
Primary Outcome Measure Information:
Title
Number of Participants With Readmission at 30 Days
Description
How many subjects were readmitted to the hospital
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Number of Participants With Readmission at 90 Days
Description
How many subjects were readmitted to the hospital
Time Frame
90 Days
Title
Number of Participants Enrolled in Clinic-based Cardiac Rehab at 90 Days
Description
Percent of patients discharged after intervention who attend at least one session of clinic-based cardiac rehab
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pradeep Natarajan, MD, MMSc
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Massachusetss General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34657825
Citation
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.
Results Reference
derived
Learn more about this trial
A Smartphone-based Application Post-myocardial Infarction to Manage Cardiovascular Disease Risk
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