Educational Intervention in Heart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT00953810
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

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 Timeline

• Study Start: 2004-04
• Primary Completion: 2007-11
• Study Completion: 2008-01
• Status Verified: 2009-08
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-05
• Last Update Submitted: 2009-08-05
• Study First Posted: 2009-08-06
• Last Update Posted: 2009-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 822

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Secondary end points included social support and quality of life.	6 months and 3 years

Trial Locations

Locations (10)

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

Oddział Kardiologiczny Szpital Wojewódzki; 🇵🇱 Ciechanow, Poland

- Klinika Chorób Wewnętrznych I Rehabilitacji Kardiologicznej; 🇵🇱 Gdańsk, Poland

Oddział Wewnętrzny Szpital Rejonowy; 🇵🇱 Grojec, Poland

Oddział Kardiologii Szpital Wojewódzki; 🇵🇱 Koszalin, Poland

- KATEDRA CHORÓB WEWNĘTRZNYCH i GERONTOLOGII; 🇵🇱 Kraków, Poland

Oddział Kardiologiczno-Internistyczny Miejski Szpital Zespolony; 🇵🇱 Olsztyn, Poland

Ii Klinika Kardiologii A.M; 🇵🇱 Poznań, Poland

Oddział Kardiologiczny Radomski Szpital Specjalistyczny; 🇵🇱 Radom, Poland

Oddział Kardiologiczny Samodzielny Specjalistyczny Szpital Wojewódzki; 🇵🇱 Siedlce, Poland