Educational Intervention in Heart Failure Patients (ZOPAN)

National Institute of Cardiology, Warsaw, Poland

Status: Completed

Conditions: Heart Failure

Treatments: Other: Educational training regarding heart failure

Study type: Interventional

Funder types: Other

Identifiers

NCT00953810

7/115/2003/101/1304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 822 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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822 participants in 2 patient groups

control

No Intervention group

Description:

General heart failure population staying under regular care of their primary care physician

Intervention

Active Comparator group

Description:

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

Treatment:

Other: Educational training regarding heart failure