Trial Outcomes & Findings for A Smartphone-based Application Post-myocardial Infarction to Manage Cardiovascular Disease Risk (NCT NCT03416920)

NCT ID: NCT03416920

Last Updated: 2023-07-17

Results Overview

How many subjects were readmitted to the hospital

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 167 participants
• Primary outcome timeframe: 30 Days
• Results posted on: 2023-07-17

Participant Flow

Participant milestones

Measure	Wellframe Subjects in this arm will use the Wellframe application for 90 days Wellframe: Wellframe mobile phone app
Overall Study STARTED	167
Overall Study COMPLETED	118
Overall Study NOT COMPLETED	49

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Wellframe n=118 Participants Subjects in this arm will use the Wellframe application for 90 days Wellframe: Wellframe mobile phone app
Age, Continuous	62.5 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	102 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Region of Enrollment United States	118 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Days

How many subjects were readmitted to the hospital

Outcome measures

Measure	Wellframe n=118 Participants Subjects in this arm will use the Wellframe application for 90 days Wellframe: Wellframe mobile phone app
Number of Participants With Readmission at 30 Days	10 Participants

SECONDARY outcome

Timeframe: 90 Days

How many subjects were readmitted to the hospital

Outcome measures

Measure	Wellframe n=118 Participants Subjects in this arm will use the Wellframe application for 90 days Wellframe: Wellframe mobile phone app
Number of Participants With Readmission at 90 Days	19 Participants

SECONDARY outcome

Timeframe: 90 days

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

Outcome measures

Measure	Wellframe n=118 Participants Subjects in this arm will use the Wellframe application for 90 days Wellframe: Wellframe mobile phone app
Number of Participants Enrolled in Clinic-based Cardiac Rehab at 90 Days	35 Participants

Adverse Events

Wellframe

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pradeep Natarajan

Massachusetts General Hospital

Phone: 617-724-3526

Email: PNATARAJAN@PARTNERS.ORG

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place