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Completed

NCT Number: NCT00953810

Educational Intervention in Heart Failure Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Failure and Transplantology Department Institute of Cardiology, Warsaw, Alpejska 42, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational training regarding heart failure

Other

Like control plus one education training regarding heart failure aspects and management

Other names: education

Primary outcomes

  1. Primary end points of the study were: death, hospitalization (including cardiovascular hospitalisation)and ambulatory visits.

    Time frame: 6 months and 3 years

Secondary outcomes

  1. Secondary end points included social support and quality of life.

    Time frame: 6 months and 3 years

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Warsaw, Poland

Other

Registry information

Official study title

RandomiZed AmbulatOry Interventional ProgrAm in Heart Failure PatieNts (ZOPAN)

Acronym: ZOPAN

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Aug 6, 2009
Registry last updated
Aug 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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