The Centre of Research Excellence (CRE) to Reduce Inequality in Heart Disease focuses on improving the heart health and outcomes of groups and communities i.e. Regional Australians, Indigenous Australians and International Health
Research Stream: Older individuals with chronic heart disease
The Nurse-led Intervention for Less Chronic Heart Failure Study was a randomised trial exploring the
potential to extend the proven benefits of multidisciplinary heart failure management programs
to those at high risk of developing the syndrome.
A randomised study of a Nurse-led Intervention for Less Chronic Heart Failure: The NIL-CHF Study
Australian New Zealand Clinical Trials Registry number 12608000022369 (http://www.anzctr.org.au)
National Health and Medical Research Council Project Grant (2008 - 2012) number 472662
This study seeks to extend the proven benefits of multidisciplinary heart failure management programs to those at high risk of developing the syndrome. Importantly, the NIL-CHF Study intervention will provide GPs and specialist physicians with information to optimise the management of their patients’ cardiovascular health. It is anticipated that the overall health of individuals will improve, requiring less intensive management and treatment.
To determine if a nurse-led, multidisciplinary, home-based intervention program for patients admitted to the Alfred Hospital (Melbourne) with a cardiovascular-related condition can prevent the development of heart failure as well as reduce hospital readmission rates, improve patients’ quality of life, prolong survival and reduce costs relative to usual post-discharge hospital and primary care. The primary objective of the NIL-CHF Study is to develop a program of care that cost-effectively prevents the development of chronic heart failure (CHF).
This is a prospective, single centre, randomised controlled trial of a sustained, post-discharge, nurse-led, multidisciplinary intervention comprising 624 individuals discharged from acute hospital care (71% male, mean age 66±11 years and free from CHF symptoms), randomised to either home-based intervention (HBI, n=309) or usual care (UC, n=315). All subjects undergo an advanced cardiovascular assessment at a dedicated outpatient clinic at 30 days post discharge (i.e. when most are clinically stable), which is repeated after 18 months for HBI and at 3 years for all subjects.
The composite primary end-point is event-free survival from a CHF-related hospitalisation or all-cause mortality during 3 to 5 years follow-up. Secondary endpoints examine the potential positive impact of the intervention from the individual (e.g. cardiac function, cognitive function, mental health and health related quality of life) and the health care system perspective (e.g. type/duration/cost of all-cause hospitalisation).
A total of 307 (97%) HBI subjects received individually tailor-designed intervention. Overall, a total of 497 (80%) surviving subjects completed final clinical assessment at 3 years post-discharge. The RCT phase of the study was completed in the first quarter of 2013 and a blinded endpoint adjudication committee is currently analysing the primary end point data.
Presentation of the primary endpoint/outcome data is scheduled for the first quarter of 2014.
Finally, you can view the 'Statistical Analysis Plan' here.
As one of the largest randomised studies of its kind, the NIL-CHF study will ultimately provide important insights into the potential to prevent CHF via prolonged and intensive secondary prevention.
The NIL-CHF study has met with the approval of the Human Research Ethics Committee of the Alfred Hospital, to continue investigating the long-term impact of the intervention and provide important insights into the natural history of progressive cardiovascular disease. A total of 459 (79%) surviving subjects have provided written informed consent for the study investigators to monitor their health outcomes until the year 2020.