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Heart Failure in Older People In Care Homes
ISRCTN ISRCTN19781227
DOI 10.1186/ISRCTN19781227
ClinicalTrials.gov identifier
EudraCT number
Public title Heart Failure in Older People In Care Homes
Scientific title Diagnosing and Managing Heart Failure in Care Homes (HFinCH): a multicentre diagnostic study and therapeutic optimisation trial
Acronym HFinCH
Serial number at source 5037
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.
Lay summary Not provided at time of registration
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
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Cardiovascular, Primary Care Research Network for England; Subtopic: Not Assigned, Cardiovascular (all Subtopics); Disease: Cardiovascular, All Diseases
Participants - 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
Participants - exclusion criteria Residents with terminal disease
Anticipated start date 01/04/2009
Anticipated end date 01/09/2010
Status of trial Completed
Patient information material
Target number of participants Planned sample size: 500; UK sample size: 500
Interventions 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
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)
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)
Sources of funding National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0407-13309)
Trial website
Publications 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
Contact name Dr  Helen  Hancock
  Address School of Medicine and Health
Old Elvet
  City/town Durham
  Zip/Postcode DH1 3HP
  Country United Kingdom
Sponsor University of Durham (UK)
  Address School of Medicine and Health
Queen’s Campus
Wolfson Research Institute
University Boulevard
  City/town Stockton-on-Tees
  Zip/Postcode TS17 6BH
  Country United Kingdom
  Sponsor website: http://www.stockton-on-tees.nhs.uk/
Date applied 28/05/2010
Last edited 09/07/2013
Date ISRCTN assigned 28/05/2010
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