HEart fAiluRe evaluaTion Questionnaire

Heart Failure Clinical Trial

— HEART  

Official title:

Observation Study for the Assessment of the "Four-point" Questionnaire by Severo and His Associates and Its Weighting in the Greek Population to Provide a Powerful Tool for Categorizing the Severity of the Symptoms of Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895073
• Other study ID #: IIS-HEART-2018
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: February 25, 2019

Study information

• Verified date: March 2019
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The "four-point" questionnaire by Severo and his associates was weighted in 2011 in the Portuguese population and aims to characterize the severity of the symptoms of heart failure by providing a way to minimize the reliability of the NYHA classification. The questionnaire consists of four closed questions, three possible single-choice answers, coded 0, 1 or 2, and has been translated into Greek in accordance with the internationally-based methodology, with forward-backward translation.

Description:

In clinical practice, the most commonly used classifications of the severity of CA⸱ are the New York Heart Association functional classification (NYHA), which is based on symptoms and exercise capacity11 and has been used in the majority of clinical trials combined with the fraction left ventricular ejection and ACC / AHA (American College of Cardiology Foundation / American Heart Association), which describes the disease according to structural lesions and symptoms.

With NYHA calibration, patients can be classified into four classes (I, II, III, IV) according to conclusions drawn from the medical history and / or observations of their physical activity and in some cases from cardiac function measurements . An attempt has been made to increase the objectivity of the method through a more comprehensive assessment, which will also be based on clinical measurements from electrocardiograms, stress tests, x-rays, echocardiograms, etc. There is a very high variability among clinicians' ratings on classifying patients in classes based on the NYHA functional classification as the class is selected according to the physician's personal assessment of the patient's physical condition. This increases the subjectivity of the particular sorting system. Studies have shown that there is agreement on NYHA calibration between different doctors for the same patient, of 55%, which leads to the conclusion that the use of this scale as the endpoint in clinical research is questionable and inadequate.

Patient self-assessments are more reliable with respect to the subjectivity of assessing the severity of symptoms. This is why maximizing the interest of the scientific community, clinicians and pharmaceutical companies in developing more subjective methods of measuring health status. 30% of all new drugs developed use patient-reported outcomes (PROs) as primary or intermediate endpoints.

The different data collection methods and sampling techniques are methods and methodologies that allow for the reduction of the amount of data to be collected, considering data only as some elements of a subset of the cases under consideration. The questionnaire is a form that includes a series of structured questions, in which the respondent is asked to respond in writing and in a specific order. Questionnaires collect data asking people to answer exactly the same set of questions. They are usually used in a research strategy to collect descriptive and explanatory data about views, behaviors, features, attitudes, etc. The questionnaire is the means of communication between the researcher and the respondents, directly or indirectly, depending on the method of data collection. The structure of the questionnaire, due to its qualities, is the most critical and delicate task, crucial to the success of a statistical survey.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 25, 2019
• Est. primary completion date: February 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• NYHA classification

• informed consent

• compliant with study procedures

Exclusion Criteria:

• no informed consent

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class I
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV

Intervention

Other:
• healthy volunteers
the questionnaire has been assessed by both groups, healthy and heart failure

Locations

Country	Name	City	State
Greece	Attikon Hospital	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
John Parissis

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	questionnaire replies	rating in Severo questionnaire	1 day