- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00953810
Educational Intervention in Heart Failure Patients (ZOPAN)
RandomiZed AmbulatOry Interventional ProgrAm in Heart Failure PatieNts (ZOPAN)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Ciechanow, Polen
- Oddział Kardiologiczny Szpital Wojewódzki
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Gdańsk, Polen
- - Klinika Chorób Wewnętrznych I Rehabilitacji Kardiologicznej
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Grojec, Polen
- Oddział Wewnętrzny Szpital Rejonowy
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Koszalin, Polen
- Oddział Kardiologii Szpital Wojewódzki
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Kraków, Polen
- - KATEDRA CHORÓB WEWNĘTRZNYCH i GERONTOLOGII
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Olsztyn, Polen
- Oddział Kardiologiczno-Internistyczny Miejski Szpital Zespolony
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Poznań, Polen
- Ii Klinika Kardiologii A.M
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Radom, Polen
- Oddział Kardiologiczny Radomski Szpital Specjalistyczny
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Siedlce, Polen
- Oddział Kardiologiczny Samodzielny Specjalistyczny Szpital Wojewódzki
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Alpejska 42
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Warsaw, Alpejska 42, Polen, 04-628
- Heart Failure and Transplantology Department Institute of Cardiology
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: control
General heart failure population staying under regular care of their primary care physician
|
|
Aktiv komparator: Intervention
Like control plus one education training regarding heart failure aspects and management
|
Like control plus one education training regarding heart failure aspects and management
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Primary end points of the study were: death, hospitalization (including cardiovascular hospitalisation)and ambulatory visits.
Tidsramme: 6 months and 3 years
|
6 months and 3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Secondary end points included social support and quality of life.
Tidsramme: 6 months and 3 years
|
6 months and 3 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Tomasz M Rywik, MD, Heart Failure and Transplantology Department Institute of Cardiology
- Hovedetterforsker: Jerzy Korewicki, Md, Ph.D, Heart Failure and Transplantology Department
- Hovedetterforsker: Wojciech Drygas, MD, Ph.D, Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology
- Hovedetterforsker: Grażyna Broda, MD, Ph.D, Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 7/115/2003/101/1304
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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