Educational Intervention in Heart Failure Patients (ZOPAN)

August 5, 2009 updated by: Institute of Cardiology, Warsaw, Poland

RandomiZed AmbulatOry Interventional ProgrAm in Heart Failure PatieNts (ZOPAN)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

822

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Ciechanow, Poland
        • Oddział Kardiologiczny Szpital Wojewódzki
      • Gdańsk, Poland
        • - Klinika Chorób Wewnętrznych I Rehabilitacji Kardiologicznej
      • Grojec, Poland
        • Oddział Wewnętrzny Szpital Rejonowy
      • Koszalin, Poland
        • Oddział Kardiologii Szpital Wojewódzki
      • Kraków, Poland
        • - KATEDRA CHORÓB WEWNĘTRZNYCH i GERONTOLOGII
      • Olsztyn, Poland
        • Oddział Kardiologiczno-Internistyczny Miejski Szpital Zespolony
      • Poznań, Poland
        • Ii Klinika Kardiologii A.M
      • Radom, Poland
        • Oddział Kardiologiczny Radomski Szpital Specjalistyczny
      • Siedlce, Poland
        • Oddział Kardiologiczny Samodzielny Specjalistyczny Szpital Wojewódzki
    • Alpejska 42
      • Warsaw, Alpejska 42, Poland, 04-628
        • Heart Failure and Transplantology Department Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary end points of the study were: death, hospitalization (including cardiovascular hospitalisation)and ambulatory visits.
Time Frame: 6 months and 3 years
6 months and 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary end points included social support and quality of life.
Time Frame: 6 months and 3 years
6 months and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 5, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7/115/2003/101/1304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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