Educational Intervention in Heart Failure Patients (ZOPAN)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Educational training regarding heart failure
Sponsored by

About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring heart failure, education, non-pharmacological management, prognosis
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
Sites / Locations
- Heart Failure and Transplantology Department Institute of Cardiology
- Oddział Kardiologiczny Szpital Wojewódzki
- - Klinika Chorób Wewnętrznych I Rehabilitacji Kardiologicznej
- Oddział Wewnętrzny Szpital Rejonowy
- Oddział Kardiologii Szpital Wojewódzki
- - KATEDRA CHORÓB WEWNĘTRZNYCH i GERONTOLOGII
- Oddział Kardiologiczno-Internistyczny Miejski Szpital Zespolony
- Ii Klinika Kardiologii A.M
- Oddział Kardiologiczny Radomski Szpital Specjalistyczny
- Oddział Kardiologiczny Samodzielny Specjalistyczny Szpital Wojewódzki
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
control
Intervention
Arm Description
General heart failure population staying under regular care of their primary care physician
Like control plus one education training regarding heart failure aspects and management
Outcomes
Primary Outcome Measures
Primary end points of the study were: death, hospitalization (including cardiovascular hospitalisation)and ambulatory visits.
Secondary Outcome Measures
Secondary end points included social support and quality of life.
Full Information
NCT ID
NCT00953810
First Posted
August 5, 2009
Last Updated
August 5, 2009
Sponsor
National Institute of Cardiology, Warsaw, Poland
1. Study Identification
Unique Protocol Identification Number
NCT00953810
Brief Title
Educational Intervention in Heart Failure Patients
Acronym
ZOPAN
Official Title
RandomiZed AmbulatOry Interventional ProgrAm in Heart Failure PatieNts (ZOPAN)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, education, non-pharmacological management, prognosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
822 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
General heart failure population staying under regular care of their primary care physician
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Like control plus one education training regarding heart failure aspects and management
Intervention Type
Other
Intervention Name(s)
Educational training regarding heart failure
Other Intervention Name(s)
education
Intervention Description
Like control plus one education training regarding heart failure aspects and management
Primary Outcome Measure Information:
Title
Primary end points of the study were: death, hospitalization (including cardiovascular hospitalisation)and ambulatory visits.
Time Frame
6 months and 3 years
Secondary Outcome Measure Information:
Title
Secondary end points included social support and quality of life.
Time Frame
6 months and 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz M Rywik, MD
Organizational Affiliation
Heart Failure and Transplantology Department Institute of Cardiology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jerzy Korewicki, Md, Ph.D
Organizational Affiliation
Heart Failure and Transplantology Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wojciech Drygas, MD, Ph.D
Organizational Affiliation
Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Grażyna Broda, MD, Ph.D
Organizational Affiliation
Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Failure and Transplantology Department Institute of Cardiology
City
Warsaw
State/Province
Alpejska 42
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Oddział Kardiologiczny Szpital Wojewódzki
City
Ciechanow
Country
Poland
Facility Name
- Klinika Chorób Wewnętrznych I Rehabilitacji Kardiologicznej
City
Gdańsk
Country
Poland
Facility Name
Oddział Wewnętrzny Szpital Rejonowy
City
Grojec
Country
Poland
Facility Name
Oddział Kardiologii Szpital Wojewódzki
City
Koszalin
Country
Poland
Facility Name
- KATEDRA CHORÓB WEWNĘTRZNYCH i GERONTOLOGII
City
Kraków
Country
Poland
Facility Name
Oddział Kardiologiczno-Internistyczny Miejski Szpital Zespolony
City
Olsztyn
Country
Poland
Facility Name
Ii Klinika Kardiologii A.M
City
Poznań
Country
Poland
Facility Name
Oddział Kardiologiczny Radomski Szpital Specjalistyczny
City
Radom
Country
Poland
Facility Name
Oddział Kardiologiczny Samodzielny Specjalistyczny Szpital Wojewódzki
City
Siedlce
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21267960
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.
Results Reference
derived
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Educational Intervention in Heart Failure Patients
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