NCT04905160

Care Coordination to Assess Improvement in Outcomes in Hospital Readmissions

Care cOordination Using Mobile Technology to Enhance Patient Empowerment in Acute Comorbidities to aSSess Improvement in Outcomes in Hospital readmissioNs

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Aventyn, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Heart failure is a syndrome that is defined by distinctive clinical, hemodynamic, and neurohormonal findings. HF represents a final common pathway for many different cardiovascular diseases, including coronary disease, hypertension, Valvular disease, and many primary heart muscle diseases. Clinically, HF patients experience dyspnea, fatigue and diminished exercise tolerance, reflecting elevated left and/or right ventricular filling pressures and decreased cardiac output.

Detailed description

Heart failure patients are frequently hospitalized and have a high mortality rate and accounts for over 1 million hospital admissions yearly in the U.S. It is associated with a 2-year mortality rate of up to 40% to 50. The annual mortality rate for Acute Decompensated Heart Failure (ADHF) is 21%. ADHF initial hospitalization mortality rates range from 4% to 7%, with mortality as high as 22% in high risk patients. About 30% to 60% of ADHF patients are readmitted within 3-6 months after discharge from the first hospitalization. Inpatient treatment for ADHF consists of diuretics, vasodilators and inotropes. Hospital admissions for ADHF have increased precipitously during the past few decades and are projected to continue to increase in the future. To optimize patient outcomes and reduce the costs associated with this disorder, evidenced-based device and pharmacotherapy is essential. Diuretics, Beta blockers, RAAS blockers and cardiac resynchronization therapy are all useful to some extent in improving outcomes of quality of life and survival. In spite of optimized therapy, there is still relentless progression of disease and clinical exacerbations of fluid retention that precipitates hospital admissions and readmissions increasing poor quality outcomes as well as the cost burden for individual, hospitals, ACOs, payers and society as a whole. There is an urgent need to decrease hospital readmissions in Post Myocardial Infarction patients and subjects with recurrent CHF. This project will use patient empowerment and new technologies to increase QOL of patients as well as to reduce readmissions

Conditions

• Heart Failure
• ADHF
• Acute MI

Interventions

Type	Name	Description
OTHER	COMPASSION Digital Biomarker	Vitals data collected by the Vitalbeat workbench for biomarker based algorithm variables will be used to drive intervention based on PAP systolic and diastolic pressures.

Timeline

• Start date: 2021-02-18
• Primary completion: 2025-02-22
• Completion: 2026-12-22
• First posted: 2021-05-27
• Last updated: 2024-03-20

Locations

1 site across 1 country: United States