NCT03416920

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

Completed NA Results posted Last updated 17 July 2023

What this trial tests

NA trial testing Wellframe in Percutaneous Coronary Intervention in 167 participants. Completed in 20 August 2019.

Timeline

12 February 2018

Primary endpoint
20 August 2019

20 August 2019

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	167
Start date	12 February 2018
Primary completion	20 August 2019
Estimated completion	20 August 2019
Sites	2 locations across United States

Drugs / interventions tested

• Wellframe

Conditions studied

• Percutaneous Coronary Intervention — all drugs for Percutaneous Coronary Intervention →

Sponsor

Massachusetts General Hospital

Who can join

Adults 21 to 85, any sex, with Percutaneous Coronary Intervention. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Readmission at 30 Days Primary · 30 Days

How many subjects were readmitted to the hospital

Group	Value	95% CI
Wellframe	10

Number of Participants With Readmission at 90 Days Secondary · 90 Days

How many subjects were readmitted to the hospital

Group	Value	95% CI
Wellframe	19

Number of Participants Enrolled in Clinic-based Cardiac Rehab at 90 Days Secondary · 90 days

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

Group	Value	95% CI
Wellframe	35

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Outcomes of a smartphone-based application with live health-coaching post-percutaneous coronary intervention.
   Paruchuri K, Finneran P, Marston NA, Healy EW, et al · · 2021 · cited 22× · PMID 34657825 · DOI 10.1016/j.ebiom.2021.103593
2. Outcomes of a Smartphone-based Application with Live Health-Coaching Post-Percutaneous Coronary Intervention
   Paruchuri K, Finneran P, Marston NA, Healy EW, et al · · 2020 · DOI 10.1101/2020.11.08.20217653