- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03895073
HEart fAiluRe evaluaTion Questionnaire (HEART)
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Attica
-
Athens, Attica, Grèce
- Attikon Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- NYHA classification
- informed consent
- compliant with study procedures
Exclusion Criteria:
- no informed consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
healthy
healthy volunteers' replies to questionnaire
|
the questionnaire has been assessed by both groups, healthy and heart failure
Autres noms:
|
|
heart failure
heart failure patients' replies the questionnaire
|
the questionnaire has been assessed by both groups, healthy and heart failure
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
questionnaire replies
Délai: 1 day
|
rating in Severo questionnaire
|
1 day
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: John Parissis, MD, Attikon Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IIS-HEART-2018
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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