Care Coordination to Assess Improvement in Outcomes in Hospital Readmissions

NCT04905160 | Recruiting

• 1 other identifier: AVDH 001
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; ADHF; Acute MI

Outcome Measures

Primary Outcomes (1)

• Reducing readmissions

  The primary objective of this study is to evaluate the efficacy of treatment strategy in reducing readmissions based on the COMPASSION algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment. Improvement of patient outcomes will be measured by reduction of composite of HF re-hospitalization and all-cause mortality through 30 days in patients with recent acute Myocardial Infarction and recent admission for decompensated heart failure.

  30 days

Secondary Outcomes (1)

• Well-being Self-assessed Likert scale at 30 days from hospitalization

  30 Days

Study Arms (2)

Subjects Hospitalized with a Primary Diagnosis of ADHF or Acute MI

EXPERIMENTAL

Phase 1 subjects 18 years or above hospitalized with a primary diagnosis of ADHF or acute MI. Patients will measure their vitals Weight, Sitting BP, Fluid Status, Heart Rate, Respiration Rate each morning for 30 days after discharge. The monitoring of this data of each patient daily will be done by dedicated H2O care team and hospitalist. The hospitalist will coordinate with the patient, the home health team, SNFs and the cardiologists as needed to correct/treat any major abnormalities picked up by the remote monitoring system in order to prevent readmissions. 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.

Other: COMPASSION Digital Biomarker

Subjects Testing Positive Covid-19 Antigen Test

EXPERIMENTAL

Phase 2 subjects 50 years or older with positive Covid-19 antigen test and one other risk factor as mentioned in the comorbid section of workflow will be enrolled in this arm of the study. Subjects will be randomized within 48 hours of Covid-19 antigen positive status. Patients will measure their vitals Weight, Sitting BP, Fluid Status, Heart Rate, Respiration Rate each morning for 30 days after discharge. The monitoring of this data of each patient daily will be done by dedicated H2O care team and hospitalist. The hospitalist will coordinate with the patient, the home health team, SNFs and the cardiologists as needed to correct/treat any major abnormalities picked up by the remote monitoring system in order to prevent readmissions. 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.

Other: COMPASSION Digital Biomarker

Interventions

COMPASSION Digital Biomarker OTHER

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.

Subjects Hospitalized with a Primary Diagnosis of ADHF or Acute MI; Subjects Testing Positive Covid-19 Antigen Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 years of age are included. Eligible subjects must be hospitalized with a primary diagnosis of ADHF or acute MI. The diagnosis of HF is established by the presence of typical symptoms, signs, and objective evidence of pulmonary congestion, elevated BNP or N-terminal pro B-type natriuretic peptide (NT-pro BNP) or impaired cardiac function. Acute MI is diagnosed by presence of chest pain, arm pain, or dyspnea with elevated Troponin and/or EKG changes suggestive of Acute coronary syndrome requiring intervention or optimal medical therapy.

You may not qualify if:

• Study informed consent will be obtained before enrollment in the study for Phase 1 and Phase 2
• For Phase 2, men and women 50 years or older with positive Covid19 antigen test and one other risk factor as mentioned in the comorbid section of workflow will be enrolled in the intervention arm of the study;
• For phase 2, subjects should be able to be randomized within 48 hours of Covid19 antigen positive status
• Patients considered unreliable by the investigator concerning the requirements for follow-up visits

Sponsors & Collaborators

• Aventyn, Inc.: lead
• TwinEpidemic: collaborator
• Arizona State University: collaborator
• Intel Corporation: collaborator
• Heart Health Organization East Valley: collaborator

Study Sites (1)

Multiple Locations

Phoenix, Arizona, 85016, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kris Vijay, MD

  Abrazo Arizona Heart

  STUDY CHAIR

• Raj Bhat, MD

  Pioneer Hospitalists

  STUDY DIRECTOR

• Zaki Lababidi, MD

  Gilbert Cardiology

  PRINCIPAL INVESTIGATOR

• Ashok Solsi, MD

  Premier Cardiovascular Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Navin Govind

CONTACT

2317942328; vitalbeat@aventyn.com

Sharolynn Mclurg

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Evaluate the efficacy of treatment strategy in reducing readmissions based on an algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment. Improvement of patient outcomes will be measured by reduction of composite of HF re-hospitalization and all-cause mortality through 30 days,90 days and 180 days in patients with recent acute Myocardial Infarction and recent admission for decompensated heart failure

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 27, 2021
• Study Start: February 18, 2021
• Primary Completion: February 22, 2025
• Study Completion (Estimated): December 22, 2026
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)