|- candidate number||8814|
|- NTR Number||NTR2663|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-dec-2010|
|- Secondary IDs||60-61900-98-303 / NL33281.068.10 ; ZonMw / METC|
|- Public Title||Hartfalen in verpleeghuizen.|
|- Scientific Title||Prevalence, diagnosis and management of heart failure in nursing home residents.|
|- hypothesis||The hypothesis is that the prevalence of heart failure is underestimated in Dutch nursing homes. In addition it is hypothesized that residents with heart failure experience a lower quality of life, have a higher degree of care dependency and have severe cognitive impairments.|
|- Healt Condition(s) or Problem(s) studied||Heart failure, Quality of life|
|- Inclusion criteria||Nursing home residents aged over 65 years and staying on chronic somatic or psychogeriatric wards.|
|- Exclusion criteria||Nursing home residents who receive palliative care and residents admitted for short-time rehabilitation.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||15-jan-2011|
|- planned closingdate||30-jun-2012|
|- Target number of participants||1000|
|- Interventions||1. Clinical examination of nursing home residents including history, physical examination, ECG, Cardiac markers (NT pro BNP) and echocardiography;|
2. Questionnaires: Care dependency scale, Qualidem, SF-12, VAS, MMSE, MDS.
|- Primary outcome||1. The prevalence of heart failure in Dutch Nursing homes. The diagnosis of heart failure is based on the decision of the panel;|
2. The predictive value to diagnose heart failure in a nursing home with a clinical assessment without using echocardiography and judgment of a panel cardiologists as golden standard is based on the percentage of cases that are diagnosed as heart failure by the NHP without the results of the echocardiogram compared to the same cases assessed by and diagnosed as heart failure by the panel using the golden standard. The nursing home physician will diagnose heart failure based on the available information about history, physical examination, NT-pro BNP value, ECG, diagnosis, co-morbidity and medication;
3. The current treatment of heart failure in nursing homes compared to the guidelines using the medication prescriptions in the nursing homes;
4. The care dependency and quality of life of nursing home residents with heart failure compared to them with no heart failure;
5. Insight in the course of heart failure after one year follow-up regarding the outcomes: heart failure events, hospital admissions for heart failure and mortality.
|- Secondary outcome||N/A|
|- Timepoints||1. After inclusion: Extensive clinical examination and questionnaries;|
2. Follow-up after one year: Questionnaries.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. M. Velden, van der - Daamen|
|- CONTACT for SCIENTIFIC QUERIES||Drs. M. Velden, van der - Daamen|
|- Sponsor/Initiator ||University Maastricht (UM), Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
Heart failure is an important and increasing problem in older people. The disease affects the experienced quality of life and care dependency negatively. Heart failure is expected to be particularly prevalent in the nursing home population but reliable data about heart failure in this specific population are lacking. Early diagnosis and treatment may lead to improvement of the signs and symptoms and improvement of quality of life; outcomes that are very important also for the nursing home population.
The prevalence, diagnosis and management of heart failure in nursing home residents will be investigated. Furthermore we look for the relation between HF versus care dependency and HF versus quality of life in nursing home residents. A one year follow-up is planned to determine whether episodes of heart failure, hospital admissions for heart failure and mortality have occurred.
The design of this multicentre study consists of a cross sectional part and a longitudinal part. Data will be collected from actual clinical examinations of nursing home residents (including history, physical examination, ECG, NT-pro BNP marker and echocardiography), patient records and questionnaires. In each resident, all examinations are performed within a period of two weeks. The collected data of the heart failure assessment will be judged by a panel of two cardiologists and a geriatrician.
Nursing home residents of five healthcare organizations, who are aged over 65 year and receiving long term somatic or psychogeriatric care.
Main study parameters/endpoints:
The study will lead to a prevalence figure of heart failure in nursing home residents, the insight of the current treatment and course of heart failure in nursing homes and will describe the experienced quality of life and care dependency.
|- Main changes (audit trail)|
|- RECORD||23-dec-2010 - 3-jan-2011|