Heart Failure in Older People In Care Homes
| 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
Scientific
School of Medicine and Health
Old Elvet
Durham
DH1 3HP
United Kingdom
Study information
| Study design | Multicentre diagnostic study randomised controlled therapeutic optimisation trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| 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 | 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 study start date | 01/04/2009 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned sample size: 500; UK sample size: 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
- England
- United Kingdom
Study participating centre
School of Medicine and Health
Durham
DH1 3HP
United Kingdom
DH1 3HP
United Kingdom
Sponsor information
University of Durham (UK)
University/education
University/education
School of Medicine and Health
Queens Campus
Wolfson Research Institute
University Boulevard
Stockton-on-Tees
TS17 6BH
England
United Kingdom
| Website | http://www.stockton-on-tees.nhs.uk/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
