Percutaneous Coronary Intervention
Conditions
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.
Interventions
OTHERWellframe
Wellframe mobile phone app
Sponsors
Boston Scientific Corporation
Wellframe, Inc.
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Enroll and onboard 150 patients with the Wellframe application
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Readmission at 30 Days | 30 Days | How many subjects were readmitted to the hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wellframe Subjects in this arm will use the Wellframe application for 90 days
Wellframe: Wellframe mobile phone app | 118 |
| Total | 118 |
Baseline characteristics
| Characteristic | Wellframe |
|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 9.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 102 Participants |
| Region of Enrollment United States | 118 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 118 |
| other Total, other adverse events | 0 / 118 |
| serious Total, serious adverse events | 0 / 118 |
Outcome results
Primary
Number of Participants With Readmission at 30 Days
How many subjects were readmitted to the hospital
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wellframe | Number of Participants With Readmission at 30 Days | 10 Participants |
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
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wellframe | Number of Participants Enrolled in Clinic-based Cardiac Rehab at 90 Days | 35 Participants |
Secondary
Number of Participants With Readmission at 90 Days
How many subjects were readmitted to the hospital
Time frame: 90 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wellframe | Number of Participants With Readmission at 90 Days | 19 Participants |