Heart Failure in Older People In Care Homes

ISRCTN	ISRCTN19781227
DOI	https://doi.org/10.1186/ISRCTN19781227
Protocol serial number	5037
Sponsor	University of Durham (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0407-13309)

Submission date: 28/05/2010
Registration date: 28/05/2010
Last edited: 09/07/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Helen Hancock
Scientific

School of Medicine and Health
Old Elvet
Durham
DH1 3HP
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre diagnostic study randomised controlled therapeutic optimisation trial
Secondary study design	Randomised controlled trial
Scientific title	Diagnosing and Managing Heart Failure in Care Homes (HFinCH): a multicentre diagnostic study and therapeutic optimisation trial
Study acronym	HFinCH
Study objectives	The purpose of this study is to explore the experiences of diagnosis and treatment of heart failure (HF) for people who are resident in care, and to ascertain the prevalence of HF in a very high risk population, with a view to providing more effective care. The study will provide vital information about the accuracy, feasibility and acceptability of the diagnostic tests used. The study will evaluate the best way of delivering improved healthcare by comparing usual NHS care with a specialist-led service. The study will allow people with heart failure to help inform the development of new and important NHS services that meet patients' needs.
Ethics approval(s)	Leeds (West) REC approved on the 3rd November 2008 (ref: 08/H1307/96)
Health condition(s) or problem(s) studied	Topic: Cardiovascular, Primary Care Research Network for England; Subtopic: Not Assigned, Cardiovascular (all Subtopics); Disease: Cardiovascular, All Diseases
Intervention	Domiciliary Heart Failure Team Care (HFTC) versus Routine Care (RC). RC will consist of test results being communicated to residents and their GPs and/or HF nurse specialists. In addition to routine care, HFTC will involve residents being visited within the home by clinical members of the research team on a number of occasions to have their findings assessed, receive educational advice, discuss options and have their medication reviewed. Study entry: Other
Intervention type	Other
Primary outcome measure(s)	1. Diagnostic phase: the proportion of residents with an incorrect (positive or negative) diagnosis determined by echocardiography 2. Trial phase: proportion of patients receiving an angiotensin converting enzyme (ACE)-inhibitor (or angiotensin receptor blocker [ARB]) and beta-blocker at therapeutic dose (6 months)
Key secondary outcome measure(s)	Diagnostic phase: 1. Prevalence of HF analyzed as a proportion 2. Proportions where HF has been missed or incorrectly identified 3. Test accuracy (sensitivity, specificity) of NT-Pro BNP, ECG and clinical signs and symptoms for the diagnosis of HF 4. Positive and negative predictive values 5. Acceptability to patients 6. Symptom profiles and quality-of-life (EuroQoL measures) Trial phase: 1. The proportion of patients dying or being hospitalised for HF (one year) 2. The proportion of patients dying or being hospitalised for any cardiovascular or cerebrovascular event (one year) 3. The net costs of providing the specialist service and change in prescribing (6 months) 4. Changes in use of other CV drugs (6 months) 5. Changes in functional capacity and quality of life (3 months)
Completion date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	500
Key inclusion criteria	1. Residential/care home managers 2. Residents of residential/care homes in Stockton-on-Tees who are aged 65 years or over, either sex 3. Health care professionals, including a representative sample of GPs, HF nurses, and care home staff, involved in care provision will be invited to participate in interviews
Key exclusion criteria	Residents with terminal disease
Date of first enrolment	01/04/2009
Date of final enrolment	01/09/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

School of Medicine and Health

Durham
DH1 3HP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	further results	01/02/2013		Yes	No
Results article	results	01/02/2013		Yes	No