Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371085
Status:
COMPLETED
Last Update Posted:
2011-09-23
First Post:
2006-08-30
Brief Title:
Congestive Heart Failure Outreach Program
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Congestive Heart Failure Outreach Program The COPE Study
Status:
COMPLETED
Status Verified Date:
2011-09
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:
COPE
Brief Summary:
Heart failure is a very common condition and is one of the main reasons people are admitted to hospital There are many things people with heart failure can do to manage their condition at home Unfortunately many people do not have enough information to do this and need to come back to the hospital because their heart failure got worse This study will look at different ways to help people learn more about heart failure and how to manage their condition at home
Detailed Description:
Background
Given the clinical and economic importance of heart failure HF widely applicable strategies to improve patient outcomes are needed In Canada14 million hospital days were associated with HF in the fiscal year 2000 and almost one-third of these were readmissions The majority of acute precipitants of HF relate to poor self-care including excessive sodium and fluid intake and nonadherence to medications Data derived from the PaKSAC survey confirm that patients with HF have very poor knowledge of their condition and self-care recommendations
Disease Management Programs for HF have been shown to improve clinical outcomes by providing intensive education and medical management Due to the resource intensity of such programs however only a limited proportion of the population at risk is served Clearly more practical educational interventions are needed
Hypothesis
An intervention consisting of a video-based educational program for patients with HF focusing on 3 key steps salt restriction daily weights and medication adherence will improve knowledge of self-care activities and clinical and economic outcomes at 6 months of follow-up
Design
A multicentre randomized control trial comparing a simple practical educational program for patients with heart failure to usual care All patients will be assessed using the validated PaKSAC survey Patient Knowledge of Self-Care Activities in Congestive Heart Failure at baseline and at 6 months Those randomized to the intervention will view a 22 minute educational video developed by our group that focuses on 3 key steps to self management A booklet and series of 3 newsletters will also be provided to the intervention group The primary outcome is the improvement in clinical outcomes at the end of the 6 month follow-up period
Given the clinical and economic importance of heart failure HF widely applicable strategies to improve patient outcomes are needed In Canada14 million hospital days were associated with HF in the fiscal year 2000 and almost one-third of these were readmissions The majority of acute precipitants of HF relate to poor self-care including excessive sodium and fluid intake and nonadherence to medications Data derived from the PaKSAC survey confirm that patients with HF have very poor knowledge of their condition and self-care recommendations
Disease Management Programs for HF have been shown to improve clinical outcomes by providing intensive education and medical management Due to the resource intensity of such programs however only a limited proportion of the population at risk is served Clearly more practical educational interventions are needed
Hypothesis
An intervention consisting of a video-based educational program for patients with HF focusing on 3 key steps salt restriction daily weights and medication adherence will improve knowledge of self-care activities and clinical and economic outcomes at 6 months of follow-up
Design
A multicentre randomized control trial comparing a simple practical educational program for patients with heart failure to usual care All patients will be assessed using the validated PaKSAC survey Patient Knowledge of Self-Care Activities in Congestive Heart Failure at baseline and at 6 months Those randomized to the intervention will view a 22 minute educational video developed by our group that focuses on 3 key steps to self management A booklet and series of 3 newsletters will also be provided to the intervention group The primary outcome is the improvement in clinical outcomes at the end of the 6 month follow-up period
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