Clinical trial NCT00953810: Educational Intervention in Heart Failure Patients
Official title: RandomiZed AmbulatOry Interventional ProgrAm in Heart Failure PatieNts (ZOPAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
education
non-pharmacological management
prognosis
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 822
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main aim of this randomized study was to evaluate the effect of educational intervention on patients with heart failure and their care-giver with regard to patients' prognosis.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary end points of the study were: death, hospitalization (including cardiovascular hospitalisation)and ambulatory visits.
timeFrame: 6 months and 3 years
Secondary outcomes:
measure: Secondary end points included social support and quality of life.
timeFrame: 6 months and 3 years
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Heart Failure and Transplantology Department Institute of Cardiology
state: Alpejska 42
city: Ciechanow
country: Poland
facility: Oddział Kardiologiczny Szpital Wojewódzki
city: Gdańsk
country: Poland
facility: - Klinika Chorób Wewnętrznych I Rehabilitacji Kardiologicznej
city: Grojec
country: Poland
facility: Oddział Wewnętrzny Szpital Rejonowy
city: Koszalin
country: Poland
facility: Oddział Kardiologii Szpital Wojewódzki
city: Kraków
country: Poland
facility: - KATEDRA CHORÓB WEWNĘTRZNYCH i GERONTOLOGII
city: Olsztyn
country: Poland
facility: Oddział Kardiologiczno-Internistyczny Miejski Szpital Zespolony
city: Poznań
country: Poland
facility: Ii Klinika Kardiologii A.M
city: Radom
country: Poland
facility: Oddział Kardiologiczny Radomski Szpital Specjalistyczny
city: Siedlce
country: Poland
facility: Oddział Kardiologiczny Samodzielny Specjalistyczny Szpital Wojewódzki
Study officials:
affiliation: Heart Failure and Transplantology Department Institute of Cardiology
name: Tomasz M Rywik, MD
role: STUDY_DIRECTOR
affiliation: Heart Failure and Transplantology Department
name: Jerzy Korewicki, Md, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology
name: Wojciech Drygas, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology
name: Grażyna Broda, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rywik TM, Kolodziej P, Targonski R, Fedyk-Lukasik M, Nowicka A, Zinka E, Zbyszynski B, Achremczyk P, Gorski J, Muder A, Sadowski J, Leszek P, Kurjata P, Broda G, Korewicki J. Characteristics of the heart failure population in Poland: ZOPAN, a multicentre national programme. Kardiol Pol. 2011;69(1):24-31.