Family Focused Nursing for outpatients with heart failure, a randomized multicenter trial
The study is designed as a randomized multi-centre trial at three Danish heart failure clinics, consecutively, including 468 patients allocated to one of two groups. Inclusion of patients started in June 2011. Patients are centrally randomized by an external online computer based system. All patients will receive standard treatment by teams specialising in heart failure. The nurse intervention, focus on identifying problems and resources, and to strengthen the family's management of the illness, in the areas of cognitive, affective and behavioural functions.
Quality of life is impaired for patients with heart failure and their next of kin, compared to other patients suffering from chronic diseases. Increased focus on relations between patients and health professionals in combination with social support from an active network might contribute to further improvement in health status of the patients. However, studies up to now have primarily used descriptive design with small population showing diverging results and variation in the definition of social support. A well designed randomised trial is needed in order to conclude whether Family Nursing Care can be justified as supplement to current course of after care of patients with heart failure and their close relatives. The purpose is to evaluate the effect of Family Focused Nursing versus conventional treatment of heart failure outpatients with respect to health-related quality of life, illness management (self-care, family resources, self-efficacy and depression) re-admissions and mortality.
Description of the cohort
Patients from three heart failure outpatient clinics at Odense University Hospital, Hospital Lillebaelt Vejle and Bispebjerg Hospital are enrolled consecutively after confirmation of the heart failure diagnosis according to the Framingham criteria based on left ventricular ejection fraction ?40%; referral to follow up nursing care in a HF clinic; New York Heart Association classification II-IV symptoms and signed informed consent. Patients who don't understand and speak Danish; who are in terminal stage of other serious diseases with a life expectancy less than six months and not able to give informed consent will excluded from the study.
Data and biological material
Information on psychosocial factors (health-related quality of life, self-care, family resources, self-efficacy and depression are obtained with the use of questionnaires.
Information on readmission and mortality are obtained from hospital's electronic register and the Civil Registration System.
Biological material from blood tests are obtained from patients and stored in a research bio-bank for analysis of pro B-type Natriuretic Peptide.
Information on demographic data (age, gender, marital status, length of education, occupation and disease duration), comorbidities (diabetes, hypertension, stroke, atrial fibrillation, myocardial infarction, chronic obstructive lung disease and previous hospitalisation for heart failure) besides pharmacologic treatment, blood pressure, heart rate and left ventricular ejection fraction, body mass index, alcohol and tobacco intake will are obtained from the hospital's electronic register and medical records, supplemented by patient information.
Collaborating researchers and departments
Clinical Institute, University of Southern Denmark
- Professor Lis Wagner, PhD
Department of Cardiology, Odense University Hospital
- Chief Consultant Lars Videbæk, PhD
OPEN Odense Patient date Explorative Network, Odense University Hospital
- Professor and Manager Torben Barington, DMSc
Institute of Nursing, Zurich University of Applied Sciences, Switzerland
- Professor Romy Mahrer-Imhof, PhD
Department of Business and Economics, University of Southern Denmark
- Professor Jørgen Lauridsen, PhD