RandomiZed AmbulatOry Interventional ProgrAm in Heart Failure PatieNts (ZOPAN)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 822
- Locations
- 10
- Primary Endpoint
- Primary end points of the study were: death, hospitalization (including cardiovascular hospitalisation)and ambulatory visits.
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Living in home nursing facilities
Arms & Interventions
control
General heart failure population staying under regular care of their primary care physician
Intervention
Like control plus one education training regarding heart failure aspects and management
Intervention: Educational training regarding heart failure (Other)
Outcomes
Primary Outcomes
Primary end points of the study were: death, hospitalization (including cardiovascular hospitalisation)and ambulatory visits.
Time Frame: 6 months and 3 years
Secondary Outcomes
- Secondary end points included social support and quality of life.(6 months and 3 years)