Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
539 participants
INTERVENTIONAL
2004-10-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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1
Video-based patient education on heart failure self care
education
Video-based educational program for heart failure focus on daily weights, medication taking, and salt restriction
Interventions
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education
Video-based educational program for heart failure focus on daily weights, medication taking, and salt restriction
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Heart and Stroke Foundation of Canada
OTHER
Merck Frosst Canada Ltd.
INDUSTRY
University of Alberta
OTHER
Responsible Party
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Ross T. Tsuyuki
Principal Investigator
Principal Investigators
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Ross T Tsuyuki, Pharm D, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
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University of Alberta Hospital & others in Canada (contact PI)
Edmonton, Alberta, Canada
Countries
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Other Identifiers
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EPICORE 2006-003
Identifier Type: -
Identifier Source: org_study_id