Heart Failure, Functional and Cognitive Decline, and Psychiatric Symptoms in Nursing Home Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00182065
Recruitment Status : Unknown
Verified August 2005 by McMaster University.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : September 11, 2006
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University

Brief Summary:
Heart failure is very common in the elderly, in whom it may lead to functional and intellectual problems. Functional problems include loss in the ability to perform basic tasks of daily living such as bathing or dressing. No studies have yet described the rate at which heart failure causes these problems to develop. This study aims to find out whether nursing home patients deteriorate more quickly with respect to function and intellect if they have heart failure. Participants will undergo a thorough health history and physical examination and will be followed every 3 months for up to a year. Over 30 nursing homes in Kitchener, Waterloo, Cambridge, and Hamilton, in South Central Ontario (Canada), are participating in this study. Every 3 months, participants will be reviewed with respect to function, intellect, mood and behaviours. Results between those with heart failure will be compared to those of people without heart failure. The results of this study will be used to plan further studies to see whether good treatment of heart failure can preserve function, intellect, and prevent depression and other mood problems.

Condition or disease
Heart Failure, Congestive

Detailed Description:

The prevalence of Heart Failure (HF) is rising, primarily among the elderly. HF has been diagnosed in 15 and 30% of elderly residents of long-term care facilities (LTCF). HF is associated with a high mortality rate and is the most common reason elderly persons are hospitalized. The economic impact of HF is substantial. Despite advances in the management of HF, the elderly are less likely to receive recommended therapies. This may reflect under-representation of the frail elderly in clinical trials of HF treatment. The elderly are more likely to experience adverse effects. In addition, HF trials have focused on mortality and hospitalization as outcome measures, which may be less relevant to the frail elderly who may be more concerned about preventing disability and preserving cognition.

Recent studies have demonstrated an association between functional decline, cognitive impairment and HF. Functional decline is defined as a loss in the ability to independently perform basic activities of self-care. In addition, patients with HF may be more likely to suffer from behavioural and psychological difficulties those without HF. The primary hypothesis of this study is that elderly residents of LTCF with a history of HF experience a more rapid rate of functional decline than residents without such a history. The secondary hypotheses are that elderly residents of LTCF with HF also experience a more rapid rate of cognitive decline and a greater burden of associated behavioural and psychological symptoms.

We propose to conduct a prospective cohort study in 25 LTCF in Hamilton, 9 LTCF in Kitchener-Waterloo, and 7 LTCF in Cambridge, all in Ontario. All newly admitted residents to these facilities will be considered for inclusion. Residents for whom consent cannot be obtained or who are not expected to survive more than eight weeks due to an underlying malignancy, end-stage neurological illness or other palliative diagnosis will be excluded. Approximately 600 patients will be recruited, 20% of which are expected to have a history of HF.

Residents for whom consent is obtained will be assessed by a research nurse. The assessment consists of a standardized history and physical examination, review of pertinent medical records, and an assessment of function (Barthel Index), cognition (MDS-COGS), and neuropsychiatric symptoms (Cohen-Mansfield Agitation Inventory and Neuropsychiatric Inventory). These measurements will be obtained at baseline and every three months thereafter for up to a year. The diagnosis of HF will be confirmed by two specialists using standard criteria. Residents with a history of HF will be compared to those without this history. Mortality, emergency room visits, acute hospitalizations, and falls will be measured.

Thus far, no studies have prospectively examined functional and cognitive decline in LTCF residents with HF. No studies have examined the relationship between HF and psychological and behavioural symptoms in these patients. As elderly residents of LTCF represent the frailest of the frail elderly, the results of this study are likely to be generalizable to the frail elderly in the community. We hope to apply the results of this study to future research aiming to determine whether treatment of HF can be optimized to reduce functional and cognitive decline in LTCF residents with HF, in order to preserve their independence and current level of disability as long as possible.

Study Type : Observational
Enrollment : 586 participants
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: The Effect of Congestive Heart Failure on Functional and Cognitive Decline and Neuropsychiatric Symptoms in Residents of Long-Term Care Facilities
Study Start Date : March 2004
Study Completion Date : October 2006

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All new residents to participating long-term care facilities
  • Age 65 or over

Exclusion Criteria:

  • Residing in any long-term care facility for more than 8 weeks
  • Inability or refusal to obtain informed consent
  • Palliative diagnosis and not expected to survive 6 weeks
  • Residents admitted for respite care and expected to be returned to the community

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00182065

Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4L8
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Principal Investigator: George A Heckman, MD McMaster University

Publications: Identifier: NCT00182065     History of Changes
Other Study ID Numbers: 117947-BCA-CEBA-126289
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: August 2005

Keywords provided by McMaster University:
Heart failure
Functional decline
Cognitive impairment
Neuropsychiatric health
Long-term care

Additional relevant MeSH terms:
Heart Failure
Cognitive Dysfunction
Heart Diseases
Cardiovascular Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders