Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
5037
Study information
Scientific title
Diagnosing and Managing Heart Failure in Care Homes (HFinCH): a multicentre diagnostic study and therapeutic optimisation trial
Acronym
HFinCH
Study hypothesis
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
Leeds (West) REC approved on the 3rd November 2008 (ref: 08/H1307/96)
Study design
Multicentre diagnostic study randomised controlled therapeutic optimisation trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Screening
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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)
Secondary outcome measures
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)
Overall trial start date
01/04/2009
Overall trial end date
01/09/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned sample size: 500; UK sample size: 500
Participant exclusion criteria
Residents with terminal disease
Recruitment start date
01/04/2009
Recruitment end date
01/09/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Medicine and Health
Durham
DH1 3HP
United Kingdom
Sponsor information
Organisation
University of Durham (UK)
Sponsor details
School of Medicine and Health
Queens Campus
Wolfson Research Institute
University Boulevard
Stockton-on-Tees
TS17 6BH
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0407-13309)
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
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23112002
2. 2013 further results in http://www.ncbi.nlm.nih.gov/pubmed/23326457
Publication citations
-
Results
Hancock HC, Close H, Mason JM, Murphy JJ, Fuat A, Singh R, Wood E, de Belder M, Brennan G, Hussain N, Kumar N, Wilson D, Hungin AP, High prevalence of undetected heart failure in long-term care residents: findings from the Heart Failure in Care Homes (HFinCH) study., Eur. J. Heart Fail., 2013, 15, 2, 158-165, doi: 10.1093/eurjhf/hfs165.
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Further results
Mason JM, Hancock HC, Close H, Murphy JJ, Fuat A, de Belder M, Singh R, Teggert A, Wood E, Brennan G, Hussain N, Kumar N, Manshani N, Hodges D, Wilson D, Hungin AP, Utility of biomarkers in the differential diagnosis of heart failure in older people: findings from the heart failure in care homes (HFinCH) diagnostic accuracy study., PLoS ONE, 2013, 8, 1, e53560, doi: 10.1371/journal.pone.0053560.