Condition category
Circulatory System
Date applied
28/05/2010
Date assigned
28/05/2010
Last edited
09/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helen Hancock

ORCID ID

Contact details

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

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
Queen’s Campus
Wolfson Research Institute
University Boulevard
Stockton-on-Tees
TS17 6BH
United Kingdom

Sponsor type

University/education

Website

http://www.stockton-on-tees.nhs.uk/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes