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Consistently Assess Signs and Symptom of Heart Failure (CLASS-HF)

Primary Purpose

Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
New York Heart Association Classification Guide
Sponsored by
Board of Trustees of Illinois State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Participant Inclusion Criteria: A documented confirmed diagnosis of Heart Failure (HF) Under the care of a Cardiologist and/or Advanced Practice Provider working in Cardiology 18 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 Participant Exclusion Criteria: 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 Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise such as, infection, thyrotoxicosis Left ventricular assist device Mental impairment leading to inability to cooperate Provider Inclusion Criteria: • Licensed healthcare providers (Physicians and Advance Practice Providers) in HF ambulatory clinical sites who care for adult patients with HF. Providers Exclusion Criteria: • Providers who do not actively manage adult patients with HF.

Sites / Locations

  • University of Colorado Medical Center
  • Carle BroMenn Medical CenterRecruiting
  • Lancaster General Health/Penn Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Intervention Study Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
March 28, 2023
Last Updated
April 17, 2023
Sponsor
Board of Trustees of Illinois State University
Collaborators
University of Colorado, Denver, Lancaster General Hospital, University of North Carolina, Greensboro, Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT05833581
Brief Title
Consistently Assess Signs and Symptom of Heart Failure
Acronym
CLASS-HF
Official Title
Examining the Reliability and Validity of the New York Heart Association Classification Guide to Assign Class for Patients With Heart Failure and Application Into Practice
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2023 (Actual)
Primary Completion Date
December 17, 2023 (Anticipated)
Study Completion Date
June 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Board of Trustees of Illinois State University
Collaborators
University of Colorado, Denver, Lancaster General Hospital, University of North Carolina, Greensboro, Abbott

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
As a continuation of prior work, the purpose of this study is to further examine the reliability and validity of the New York Heart Association (NYHA) Classification Guide and application into practice. The investigators will conduct 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]). HF providers will be asked to complete the NYHA classification Guide and assign one of 4 functional classes: Class I, Class II, Class III, or Class IV. Participants will then complete a standardized 6-minute walk test (6MWT), 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. Clinicians will utilize the NYHA Classification Guide for 30 days and will report perceived barriers and facilitators. Data reporting NYHA Class and HF Stage will be obtained from 30 days prior implementation and compared to during implementation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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]).
Masking
None (Open Label)
Masking Description
For the 6-minute walk test the technician performing the test is masked. The remainder of the data is not masked.
Allocation
N/A
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Intervention Study Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
New York Heart Association Classification Guide
Intervention Description
The New York Heart Association Classification Guide is a questionnaire that assists in guiding the provider in selection of the patient's class
Primary Outcome Measure Information:
Title
Reliability of the New York Heart Association (NYHA) Classification Guide
Description
Experts will assign NYHA class using the guide in 30 selected clinical records. The assigned class results will be compared to determine reliability.
Time Frame
12 weeks
Title
Validity of the New York Heart Association (NYHA) Classification Guide
Description
Providers will assign NYHA class using the guide to assess participants with HF who will then perform a 6-minute walk test.
Time Frame
1 year
Title
Barriers to implementation of the New York Heart Association (NYHA) Classification Guide
Description
Providers will be surveyed following 30-days of using the NYHA Classification Guide in the clinical setting regarding perceived barriers to implementation into practice.
Time Frame
30-days
Title
Facilitators to implementation of the New York Heart Association (NYHA) Classification Guide
Description
Providers will be surveyed following 30-days of using the NYHA Classification Guide in the clinical setting regarding perceived facilitators to implementation into practice.
Time Frame
30-days
Title
Documentation after Implementation of the New York Heart Association (NYHA) Classification Guide
Description
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).
Time Frame
60-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Participant Inclusion Criteria: A documented confirmed diagnosis of Heart Failure (HF) Under the care of a Cardiologist and/or Advanced Practice Provider working in Cardiology 18 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 Participant Exclusion Criteria: 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 Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise such as, infection, thyrotoxicosis Left ventricular assist device Mental impairment leading to inability to cooperate Provider Inclusion Criteria: • Licensed healthcare providers (Physicians and Advance Practice Providers) in HF ambulatory clinical sites who care for adult patients with HF. Providers Exclusion Criteria: • Providers who do not actively manage adult patients with HF.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marilyn A. Prasun, PhD
Phone
217-433-2316
Email
maprasu@ilstu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly D. Stamp, PhD
Phone
303-724-8398
Email
Kelly.Stamp@CUAnschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn A. Prasun, PhD
Organizational Affiliation
Board of Trustees of Illinois State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Medical Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly D. Stamp, PhD
Phone
303-724-8398
Email
Kelly.Stamp@CUAnschutz.edu
Facility Name
Carle BroMenn Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dory Jarzabkowski, DO
Phone
309-556-8300
Email
dory.jarzabkowski@carle.com
First Name & Middle Initial & Last Name & Degree
Tami Tallyn, RN
Phone
309-556-8300
Email
tami.tallyn@carle.com
Facility Name
Lancaster General Health/Penn Medicine
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa D Rathman, MS
Phone
717-397-5484
Email
Lisa.Rathman@pennmedicine.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate data will be published.
Links:
URL
http://doi.org/10.1016/j.hrtlng.2022.03.017
Description
Providers' Accuracy in Decision-Making with Assessing NYHA Functional Class of Patients with Heart Failure after use of a Classification Guide
URL
http://doi.org/10.1016/j.hrtlng.2021.07.009
Description
Providers' assignment of NYHA functional class in patients with heart failure: A vignette study

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Consistently Assess Signs and Symptom of Heart Failure

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