NCT00182065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
586

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2006

Completed
7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2013

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

2.8 years

First QC Date

September 9, 2005

Last Update Submit

March 21, 2023

Conditions

Keywords

Heart failureFunctional declineCognitive impairmentNeuropsychiatric healthLongitudinalLong-term careElderly

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (2)

  • 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.

    PMID: 15776118BACKGROUND
  • Heckman 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.

    PMID: 15332144BACKGROUND

MeSH Terms

Conditions

Heart FailureCognitive Dysfunction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • George A Heckman, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

March 1, 2004

Primary Completion

November 30, 2006

Study Completion

December 31, 2013

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations