Congestive Heart Failure Outreach Program (COPE)

This study has been completed.
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
Ross T. Tsuyuki, University of Alberta
ClinicalTrials.gov Identifier:
NCT00371085
First received: August 30, 2006
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Heart Failure
Behavioral: education
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Congestive Heart Failure Outreach Program (The COPE Study)

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in all-cause hospitalizations between groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Differences in CHF-related hospitalizations between groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Differences in total number of in-hospital days between groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 539
Study Start Date: October 2004
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Video-based patient education on heart failure self care
Behavioral: education
Video-based educational program for heart failure focus on daily weights, medication taking, and salt restriction

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371085

Locations
Canada, Alberta
University of Alberta Hospital & others in Canada (contact PI)
Edmonton, Alberta, Canada, T6G 2C8
Sponsors and Collaborators
University of Alberta
Heart and Stroke Foundation of Canada
Merck Frosst Canada Ltd.
Investigators
Principal Investigator: Ross T Tsuyuki, Pharm D, MSc University of Alberta
  More Information

No publications provided

Responsible Party: Ross T. Tsuyuki, Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier: NCT00371085     History of Changes
Other Study ID Numbers: EPICORE 2006-003
Study First Received: August 30, 2006
Last Updated: September 22, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
heart failure
quality improvement
patient education
health care economics

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014