Educational Intervention in Heart Failure Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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RandomiZed AmbulatOry Interventional ProgrAm in Heart Failure PatieNts (ZOPAN)

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Educational training regarding heart failure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>General heart failure population staying under regular care of their primary care physician | |
| Active Comparator: Intervention<br>Like control plus one education training regarding heart failure aspects and management | Other: Educational training regarding heart failure<br>* Like control plus one education training regarding heart failure aspects and management<br>* Other names: education;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, education, non-pharmacological management, prognosis