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Completed

NCT Number: NCT00371085

Congestive Heart Failure Outreach Program

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alberta Hospital & others in Canada (contact PI)

Edmonton, Alberta, T6G 2C8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Differences in all-cause hospitalizations between groups

    Time frame: 6 months

  2. Differences in CHF-related hospitalizations between groups

    Time frame: 6 months

  3. Differences in total number of in-hospital days between groups

    Time frame: 6 months

  4. 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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Heart and Stroke Foundation of Canada
  • Merck Frosst Canada Ltd.

Registry information

Official study title

Congestive Heart Failure Outreach Program (The COPE Study)

Acronym: COPE

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Sep 1, 2006
Registry last updated
Sep 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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