ISRCTN ISRCTN19781227
DOI https://doi.org/10.1186/ISRCTN19781227
Secondary identifying numbers 5037
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

Study designMulticentre diagnostic study randomised controlled therapeutic optimisation trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeScreening
Scientific titleDiagnosing and Managing Heart Failure in Care Homes (HFinCH): a multicentre diagnostic study and therapeutic optimisation trial
Study acronymHFinCH
Study objectivesThe 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) studiedTopic: Cardiovascular, Primary Care Research Network for England; Subtopic: Not Assigned, Cardiovascular (all Subtopics); Disease: Cardiovascular, All Diseases
InterventionDomiciliary 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 typeOther
Primary outcome measure1. 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 measuresDiagnostic 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 study start date01/04/2009
Completion date01/09/2010

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsPlanned sample size: 500; UK sample size: 500
Key inclusion criteria1. 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 criteriaResidents with terminal disease
Date of first enrolment01/04/2009
Date of final enrolment01/09/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

School of Medicine and Health
Durham
DH1 3HP
United Kingdom

Sponsor information

University of Durham (UK)
University/education

School of Medicine and Health
Queen’s Campus
Wolfson Research Institute
University Boulevard
Stockton-on-Tees
TS17 6BH
England
United Kingdom

Website http://www.stockton-on-tees.nhs.uk/
ROR logo "ROR" https://ror.org/01v29qb04

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0407-13309)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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