Educational Intervention in Heart Failure Patients

NCT ID: NCT00953810

Last Updated: 2009-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 822 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2008-01-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type: ACTIVE_COMPARATOR

Educational training regarding heart failure

Intervention Type: OTHER

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

Interventions

Educational training regarding heart failure

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

Intervention Type: OTHER

Other Intervention Names

education

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role: lead

Responsible Party

Institute of Cardiology

Principal Investigators

Tomasz M Rywik, MD

Role: STUDY_DIRECTOR

Heart Failure and Transplantology Department Institute of Cardiology

Jerzy Korewicki, Md, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Heart Failure and Transplantology Department

Wojciech Drygas, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology

Grażyna Broda, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology

Locations

Heart Failure and Transplantology Department Institute of Cardiology

Warsaw, Alpejska 42, Poland

Oddział Kardiologiczny Szpital Wojewódzki

Ciechanów, , Poland

- Klinika Chorób Wewnętrznych I Rehabilitacji Kardiologicznej

Gdansk, , Poland

Oddział Wewnętrzny Szpital Rejonowy

Grójec, , Poland

Oddział Kardiologii Szpital Wojewódzki

Koszalin, , Poland

- KATEDRA CHORÓB WEWNĘTRZNYCH i GERONTOLOGII

Krakow, , Poland

Oddział Kardiologiczno-Internistyczny Miejski Szpital Zespolony

Olsztyn, , Poland

Ii Klinika Kardiologii A.M

Poznan, , Poland

Oddział Kardiologiczny Radomski Szpital Specjalistyczny

Radom, , Poland

Oddział Kardiologiczny Samodzielny Specjalistyczny Szpital Wojewódzki

Siedlce, , Poland

Countries

Poland

References

Rywik TM, Kolodziej P, Targonski R, Fedyk-Lukasik M, Nowicka A, Zinka E, Zbyszynski B, Achremczyk P, Gorski J, Muder A, Sadowski J, Leszek P, Kurjata P, Broda G, Korewicki J. Characteristics of the heart failure population in Poland: ZOPAN, a multicentre national programme. Kardiol Pol. 2011;69(1):24-31.

Reference Type: DERIVED

PMID: 21267960 (View on PubMed)

Other Identifiers

7/115/2003/101/1304

Identifier Type: -

Identifier Source: org_study_id