- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00953810
Educational Intervention in Heart Failure Patients (ZOPAN)
RandomiZed AmbulatOry Interventional ProgrAm in Heart Failure PatieNts (ZOPAN)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Part I: This is a multicenter study on the effect of educational intervention on heart failure patients and their caregivers with respect to patients' prognosis, social support and quality of life. Subsequent patients with heart failure (based on the inclusion criteria) coming to selected, ambulatory physician, were randomized to either a control or intervention group. Both groups underwent questionnaire evaluation regarding clinical assessment and evaluation of familiarity with aspects of heart failure along with social support and quality of life. Clinical assessment included information on demography, social status, medical history, pharmacotherapy, diagnostic procedures, and utilization of health system resources. After recruitment, patients from intervention group and their caregivers underwent one educational training, during which they received materials on the management of heart failure. Before the meeting, data on familiarity with heart failure were acquired from patients' relatives. During further follow up all participants stayed under regular care from their ambulatory physicians. After 6 months patients underwent short term evaluation based on designated questionnaires, with special attention paid to hospitalization and ambulatory visits due to heart failure. Also data on heart failure knowledge, social support and quality of life was collected. Without any further intervention, follow up was continued. Next long term assessment was undertaken after approximately 3 years from the recruitment. As previously patients fulfilled questionnaires regarding information on their familiarity with heart failure management and social support as well as quality of life. Primary end points of the study were: death, hospitalization (including cardiovascular hospitalizations) and ambulatory visits. Secondary end points included social support and quality of life.
Sub-study: genetic polymorphism - blood specimens collected during one of the visits and stored for further evaluation in future. Study population - all main study participants who gave their informed consent to this part of protocol. Aims: to describe the potential of selected genes candidates polymorphism on the heart failure prognosis and survival in patients NYHA class II-IV.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ciechanow, Pologne
- Oddział Kardiologiczny Szpital Wojewódzki
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Gdańsk, Pologne
- - Klinika Chorób Wewnętrznych I Rehabilitacji Kardiologicznej
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Grojec, Pologne
- Oddział Wewnętrzny Szpital Rejonowy
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Koszalin, Pologne
- Oddział Kardiologii Szpital Wojewódzki
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Kraków, Pologne
- - KATEDRA CHORÓB WEWNĘTRZNYCH i GERONTOLOGII
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Olsztyn, Pologne
- Oddział Kardiologiczno-Internistyczny Miejski Szpital Zespolony
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Poznań, Pologne
- Ii Klinika Kardiologii A.M
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Radom, Pologne
- Oddział Kardiologiczny Radomski Szpital Specjalistyczny
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Siedlce, Pologne
- Oddział Kardiologiczny Samodzielny Specjalistyczny Szpital Wojewódzki
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Alpejska 42
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Warsaw, Alpejska 42, Pologne, 04-628
- Heart Failure and Transplantology Department Institute of Cardiology
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria
- Symptoms of heart failure
- EF < 45% (during past 2 years) or abnormal ECG and chest x-ray when echo unavailable
- Age > 18 years
- Signed informed consent
Exclusion Criteria:
- Severe COPD
- Serious comorbidities, influencing life expectancy or quality of life
- Alcohol and drug addict
- Post MI less than 6 months
- Dementia
- Living in home nursing facilities
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: control
General heart failure population staying under regular care of their primary care physician
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Comparateur actif: Intervention
Like control plus one education training regarding heart failure aspects and management
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Like control plus one education training regarding heart failure aspects and management
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Primary end points of the study were: death, hospitalization (including cardiovascular hospitalisation)and ambulatory visits.
Délai: 6 months and 3 years
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6 months and 3 years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Secondary end points included social support and quality of life.
Délai: 6 months and 3 years
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6 months and 3 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Tomasz M Rywik, MD, Heart Failure and Transplantology Department Institute of Cardiology
- Chercheur principal: Jerzy Korewicki, Md, Ph.D, Heart Failure and Transplantology Department
- Chercheur principal: Wojciech Drygas, MD, Ph.D, Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology
- Chercheur principal: Grażyna Broda, MD, Ph.D, Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
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
- 7/115/2003/101/1304
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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