Heart Failure, CongestiveNCT00182065
Heart Failure, Functional and Cognitive Decline, and Psychiatric Symptoms in Nursing Home Patients
An observational study of Heart Failure, Congestive, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Congestive
- How many people
- 586 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2004to 31 Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All new residents to participating long-term care facilities
- Age 65 or over
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Congestive Heart Failure on Functional and Cognitive Decline and Neuropsychiatric Symptoms in Residents of Long-term Care Facilities
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.
Read the 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.
- Conditions
- Heart Failure, Congestive
- Keywords
- Heart failure, Functional decline, Cognitive impairment, Neuropsychiatric health, Longitudinal, Long-term care, Elderly
- Medical subject headings
- Heart Failure, Cognitive Dysfunction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start1 Mar 2004
- Primary completion30 Nov 2006
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 586 participants
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- George A Heckman, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182065
- Sponsor's protocol ID
- 117947-BCA-CEBA-126289
- Status last verified
- Mar 2023
- First submitted
- 9 Sep 2005
- Last updated
- 23 Mar 2023
- Results posted
- No
Publications
Misiaszek B, Heckman GA, Merali F, Turpie ID, Patterson CJ, Flett N, McKelvie RS. Digoxin prescribing for heart failure in elderly residents of long-term care facilities. Can J Cardiol. 2005 Mar;21(3):281-6.
PubMed 15776118Heckman GA, Misiaszek B, Merali F, Turpie ID, Patterson CJ, Flett N, McKelvie RS. Management of heart failure in Canadian long-term care facilities. Can J Cardiol. 2004 Aug;20(10):963-9.
PubMed 15332144
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Congestive Heart Failure on Functional and Cognitive Decline and Neuropsychiatric Symptoms in Residents of Long-term Care Facilities
- ClinicalTrials.gov ID
- NCT00182065
- Acronym / sponsor ID
- 117947-BCA-CEBA-126289
- Conditions
- Heart Failure, Congestive
- Keywords
- Heart failure, Functional decline, Cognitive impairment, Neuropsychiatric health, Longitudinal, Long-term care, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 586 participants
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Mar 2004 (actual)
- Primary completion
- 30 Nov 2006 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- All new residents to participating long-term care facilities
- Age 65 or over
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 15776118Misiaszek B, Heckman GA, Merali F, Turpie ID, Patterson CJ, Flett N, McKelvie RS. Digoxin prescribing for heart failure in elderly residents of long-term care facilities. Can J Cardiol. 2005 Mar;21(3):281-6.
- Background: PubMed 15332144Heckman GA, Misiaszek B, Merali F, Turpie ID, Patterson CJ, Flett N, McKelvie RS. Management of heart failure in Canadian long-term care facilities. Can J Cardiol. 2004 Aug;20(10):963-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George A Heckman, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Congestive, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182065, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.