Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RJ1 05/0206
Study information
Scientific title
Acronym
Study hypothesis
Does a nurse led service improve outcomes for people with chronic heart failure? The principal objective is to reduce overall bed days by recurrent hospitalisations which is a common feature of this complex chronic disease. It is anticipated that by introducing a new nurse led service that will educate, monitor and advise patients and their family/carers, clinical deterioration will be noted early and acted upon. The intervention will promote the role of the patient in the monitoring and management of this long term chronic disease.
Ethics approval
The local medical ethics committee approved on the 7th of September 2005 (ref: 05/Q0707/51)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic Heart Failure
Intervention
Nurse intervention will include two visits from the Heart Failure Specialist Nurse or Nurse Consultant during the patients in-patient stay, telephone contact will be made within one week of discharge and the patient will be seen in the nurse-led clinic within 2 weeks of discharge, subsequent nurse-led clinic visits will then continue after this period. The nurse led intervention will include support and education about the disease and treatments and guidance on how to manage at home. This group of patients will be provided with a hand-held record which contains information such as medication list, test results, weight chart etc.
Control: standard care delivery
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Number of episodes of readmission with main diagnosis of heart failure and bed days utilized over a 12 month period.
Secondary outcome measures
1. Use of appropriate medication
2. Self care management strategies
3. Quality of life
4. Patient illness perceptions
Overall trial start date
01/11/2005
Overall trial end date
01/11/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Main diagnosis of Heart Failure as demonstrated on echocardiogram - using the European Society of Cardiology guidelines and National Institute for Clinical Excellence (NICE) guidelines.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
170 patients (85 each group)
Participant exclusion criteria
1. Patients already exposed to a nurse led heart failure clinic
2. Patients unable to visit the clinic
3. Patients with dementia or other psychiatric disorder
4. Patients with a short anticipated survival (e.g. malignancy)
Recruitment start date
01/11/2005
Recruitment end date
01/11/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiology Administration
London
SE1 7EH
United Kingdom
Funders
Funder type
Government
Funder name
Guy's & St Thomas' NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary