Consistently Assess Signs and Symptom of Heart Failure

NCT05833581 | Unknown DMC

• 1 other identifier: HF-2021-000136
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 3

Brief Summary

Heart failure (HF) is a major public health problem. The New York Heart Association (NYHA) Functional Classification by a HF provider helps to guide their decisions in patient treatment. The purpose of this study is to further examine the NYHA Classification Guide that is designed to assist healthcare providers. The investigators will conduct the study in the outpatient clinic setting where adult patients with chronic heart failure are treated. HF providers will be asked to complete the NYHA classification Guide and then participants will complete a standardized 6-minute walk test which is considered as the gold standard. Participant results will be compared between providers' assigned class and the results from the 6-minute walk test. The subsequent phase of the study will be incorporation of the NYHA Classification Guide into clinical practice. HF providers will use the NYHA Classification Guide for 30 days in the clinic setting and will report their perceptions.

Conditions

Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (5)

• Reliability of the New York Heart Association (NYHA) Classification Guide

  Experts will assign NYHA class using the guide in 30 selected clinical records. The assigned class results will be compared to determine reliability.

  12 weeks

• Validity of the New York Heart Association (NYHA) Classification Guide

  Providers will assign NYHA class using the guide to assess participants with HF who will then perform a 6-minute walk test.

  1 year

• Barriers to implementation of the New York Heart Association (NYHA) Classification Guide

  Providers will be surveyed following 30-days of using the NYHA Classification Guide in the clinical setting regarding perceived barriers to implementation into practice.

  30-days

• Facilitators to implementation of the New York Heart Association (NYHA) Classification Guide

  Providers will be surveyed following 30-days of using the NYHA Classification Guide in the clinical setting regarding perceived facilitators to implementation into practice.

  30-days

• Documentation after Implementation of the New York Heart Association (NYHA) Classification Guide

  30-days prior and 30-days during implementation of the NYHA Classification Guide in clinical practice, the provider clinic notes from the patient visit will be assessed for documentation of NYHA class (I-IV) and HF stage (A-D).

  60-days

Study Arms (1)

Single Intervention Study Arm

EXPERIMENTAL

All participants with HF will be evaluated by their HF providers who will use the NYHA Classification Guide to assist with assignment of HF class. The participant will then complete a 6-minute walk test. Subsequently participating providers will utilize the guide to assess and assign the class of their HF patients in practice.

Other: New York Heart Association Classification Guide

Interventions

New York Heart Association Classification Guide OTHER

The New York Heart Association Classification Guide is a questionnaire that assists in guiding the provider in selection of the patient's class

Single Intervention Study Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A documented confirmed diagnosis of Heart Failure (HF)
• Under the care of a Cardiologist and/or Advanced Practice Provider working in Cardiology
• years of age or older and less than 90 years of age
• Alert and oriented to person, place, and time
• Ability to walk without assistance
• Able to read and speak English

You may not qualify if:

• Diagnosed with myocardial infarction, coronary artery bypass graft (CABG), angioplasty or stent in the previous 30-days
• Unstable angina in the previous 30 days
• Active endocarditis
• Acute myocarditis or pericarditis
• Symptomatic severe aortic stenosis
• Uncontrolled hypertension with systolic blood pressure readings \> 180 mmHg or diastolic pressure readings \> 100 mmHg
• Uncontrolled atrial dysrhythmia or 3rd degree heart block
• Active ventricular arrhythmias resulting in 1 or more shocks in the past month
• Acute pulmonary embolus or pulmonary infection
• Thrombosis of the lower extremities
• Suspected dissecting aneurysm
• Uncontrolled asthma
• Pulmonary edema
• Room air oxygen saturation (SPO2) at rest less than 90%
• Acute respiratory failure

Sponsors & Collaborators

• Board of Trustees of Illinois State University: lead
• University of Colorado, Denver: collaborator
• Lancaster General Hospital: collaborator
• University of North Carolina, Greensboro: collaborator
• Abbott: collaborator

Study Sites (3)

University of Colorado Medical Center

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Carle BroMenn Medical Center

Normal, Illinois, 61761, United States

RECRUITING

Lancaster General Health/Penn Medicine

Lancaster, Pennsylvania, 17602, United States

NOT YET RECRUITING

Related Links

• Providers' Accuracy in Decision-Making with Assessing NYHA Functional Class of Patients with Heart Failure after use of a Classification Guide
• Providers' assignment of NYHA functional class in patients with heart failure: A vignette study

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Marilyn A. Prasun, PhD

  Board of Trustees of Illinois State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marilyn A. Prasun, PhD

CONTACT

217-433-2316; maprasu@ilstu.edu

Kelly D. Stamp, PhD

CONTACT

303-724-8398; Kelly.Stamp@CUAnschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: For the 6-minute walk test the technician performing the test is masked. The remainder of the data is not masked.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Carle BroMenn Medical Center Endowed Professor

Model Details: A prospective cross-sectional study in the ambulatory care settings that manages adult patients with chronic heart failure (both heart failure with reduced ejection fraction \[HFrEF\] and heart failure with preserved ejection fraction \[HFpEF\]).

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 27, 2023
• Study Start: March 17, 2023
• Primary Completion: December 17, 2023
• Study Completion: June 17, 2024
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)