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Congestive Heart Failure Outreach Program

Congestive Heart Failure Outreach Program (The COPE Study)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00371085
Acronym
COPE
Enrollment
539
Registered
2006-09-01
Start date
2004-10-31
Completion date
2010-12-31
Last updated
2011-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, quality improvement, patient education, health care economics

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 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. 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.

Interventions

BEHAVIORALeducation

Video-based educational program for heart failure focus on daily weights, medication taking, and salt restriction

Sponsors

Heart and Stroke Foundation of Canada
CollaboratorOTHER
Merck Frosst Canada Ltd.
CollaboratorINDUSTRY
University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patient in hospital or emergency room with symptomatic CHF confirmed by a physician. * patient seen in an outpatient clinic with symptomatic CHF confirmed by a physician, AND hospitalized within the previous 6 months for heart failure. * age greater than 18 years.

Exclusion criteria

* asymptomatic CHF * life expectancy \< 6 months * receiving chronic hemodialysis or peritoneal dialysis * unable to communicate (non-English speaking, intubated, etc) * demented or a mental illness which precludes participation * receives professional assistance for self-care activities including meals or medications (e.g. nursing home) * previously enrolled in this study * participation in another heart failure study, or * declined to participate

Design outcomes

Primary

MeasureTime frame
Differences in clinical outcomes, as measured by cardiovascular hospitalizations and emergency room presentations, between video-based education and usual care groups.6 months

Secondary

MeasureTime frame
Differences in all-cause hospitalizations between groups6 months
Differences in CHF-related hospitalizations between groups6 months
Differences in total number of in-hospital days between groups6 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 groups6 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026