Educational Intervention in Heart Failure Patients (ZOPAN)

This study has been completed.
Sponsor:
Information provided by:
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT00953810
First received: August 5, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Heart Failure
Other: Educational training regarding heart failure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: RandomiZed AmbulatOry Interventional ProgrAm in Heart Failure PatieNts (ZOPAN)

Resource links provided by NLM:


Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • Primary end points of the study were: death, hospitalization (including cardiovascular hospitalisation)and ambulatory visits. [ Time Frame: 6 months and 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary end points included social support and quality of life. [ Time Frame: 6 months and 3 years ] [ Designated as safety issue: No ]

Enrollment: 822
Study Start Date: April 2004
Study Completion Date: January 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
General heart failure population staying under regular care of their primary care physician
Active Comparator: Intervention
Like control plus one education training regarding heart failure aspects and management
Other: Educational training regarding heart failure
Like control plus one education training regarding heart failure aspects and management
Other Name: education

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953810

Locations
Poland
Heart Failure and Transplantology Department Institute of Cardiology
Warsaw, Alpejska 42, Poland, 04-628
Oddział Kardiologiczny Szpital Wojewódzki
Ciechanow, Poland
- Klinika Chorób Wewnętrznych I Rehabilitacji Kardiologicznej
Gdańsk, Poland
Oddział Wewnętrzny Szpital Rejonowy
Grojec, Poland
Oddział Kardiologii Szpital Wojewódzki
Koszalin, Poland
- KATEDRA CHORÓB WEWNĘTRZNYCH i GERONTOLOGII
Kraków, Poland
Oddział Kardiologiczno-Internistyczny Miejski Szpital Zespolony
Olsztyn, Poland
Ii Klinika Kardiologii A.M
Poznań, Poland
Oddział Kardiologiczny Radomski Szpital Specjalistyczny
Radom, Poland
Oddział Kardiologiczny Samodzielny Specjalistyczny Szpital Wojewódzki
Siedlce, Poland
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
Study Director: Tomasz M Rywik, MD Heart Failure and Transplantology Department Institute of Cardiology
Principal Investigator: Jerzy Korewicki, Md, Ph.D Heart Failure and Transplantology Department
Principal Investigator: Wojciech Drygas, MD, Ph.D Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology
Principal Investigator: Grażyna Broda, MD, Ph.D Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology
  More Information

No publications provided by Institute of Cardiology, Warsaw, Poland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tomasz M. Rywik MD,Ph.D., Institute of Cardiology
ClinicalTrials.gov Identifier: NCT00953810     History of Changes
Other Study ID Numbers: 7/115/2003/101/1304
Study First Received: August 5, 2009
Last Updated: August 5, 2009
Health Authority: Poland: Ministry of Health

Keywords provided by Institute of Cardiology, Warsaw, Poland:
heart failure
education
non-pharmacological management
prognosis

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014