Congestive Heart Failure Outreach Program (COPE)

Congestive Heart Failure Outreach Program (The COPE Study)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: education

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.

• Study Type: Interventional
• Enrollment (Actual): 539
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2C8
      • University of Alberta Hospital & others in Canada (contact PI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Time Frame
Differences in all-cause hospitalizations between groups	6 months
Differences in CHF-related hospitalizations between groups	6 months
Differences in total number of in-hospital days between groups	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	6 months

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Merck Frosst Canada Ltd.; Heart and Stroke Foundation of Canada
• Investigators: Principal Investigator: Ross T Tsuyuki, Pharm D, MSc, University of Alberta

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: August 30, 2006
• First Submitted That Met QC Criteria: August 31, 2006
• First Posted (ESTIMATE): September 1, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): September 23, 2011
• Last Update Submitted That Met QC Criteria: September 22, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: patient education; heart failure; quality improvement; health care economics
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: EPICORE 2006-003