Congestive Heart Failure Outreach Program (COPE)
|ClinicalTrials.gov Identifier: NCT00371085|
Recruitment Status : Completed
First Posted : September 1, 2006
Last Update Posted : September 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Behavioral: education||Phase 4|
Given the clinical and economic importance of heart failure (HF) widely applicable strategies to improve patient outcomes are needed. In Canada,1.4 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.
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||539 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Congestive Heart Failure Outreach Program (The COPE Study)|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Video-based patient education on heart failure self care
Video-based educational program for heart failure focus on daily weights, medication taking, and salt restriction
- Differences in clinical outcomes, as measured by cardiovascular hospitalizations and emergency room presentations, between video-based education and usual care groups. [ Time Frame: 6 months ]
- Differences in all-cause hospitalizations between groups [ Time Frame: 6 months ]
- Differences in CHF-related hospitalizations between groups [ Time Frame: 6 months ]
- Differences in total number of in-hospital days between groups [ Time Frame: 6 months ]
- Change in CHF knowledge levels from the initial in-hospital patient contact to the end of the 6 month follow-up between the two groups [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371085
|University of Alberta Hospital & others in Canada (contact PI)|
|Edmonton, Alberta, Canada, T6G 2C8|
|Principal Investigator:||Ross T Tsuyuki, Pharm D, MSc||University of Alberta|