Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182065
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2005-09-09
Brief Title:
Heart Failure Functional and Cognitive Decline and Psychiatric Symptoms in Nursing Home Patients
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
The Effect of Congestive Heart Failure on Functional and Cognitive Decline and Neuropsychiatric Symptoms in Residents of Long-term Care Facilities
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None