Evaluation of a Primary Care Based Heart Failure Management Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00182182
Recruitment Status : Unknown
Verified September 2006 by McMaster University.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : September 11, 2006
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University

Brief Summary:
Evaluation of a primary care based (family physicians) HF management strategy in patients with heart failure in the community

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Primary care based disease management strategy Phase 2 Phase 3

Detailed Description:
Cluster randomized clinical trial (family physician is cluster) evaluating a primary care based heart failure management strategy

Study Type : Interventional  (Clinical Trial)
Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Congestive Heart Failure Assessment and Management in Primary Care: CHAMP
Study Start Date : July 2003
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Primary Outcome Measures :
  1. Process-of-care composite score assessed at baseline, at 6 months for effectiveness of the intervention, and at 12 months for sustainability of the effect. The score includes assessment of:
  2. ACE-inhibitor use unless contraindicated,ACE-inhibitor dosage is at >50% of clinical trial target dose,Beta-blocker use unless contraindicated.
  3. Each component of the score will be given one point.

Secondary Outcome Measures :
  1. Disease specific quality of life (QOL)with Minnessota Living with Heart Failure.
  2. NYHA functional class.
  3. Other outcomes
  4. All-cause hospitalization defined as > 24-hour hospital stay including the time spent in the emergency room.
  5. Hospitalizations for HF: > 24-hour hospital stay including the time spent in the emergency room with clinical evidence of HF including at least one of the following: increased dyspnea on exertion, orthopnea, nocturnal dyspnea, elevated jugular venous
  6. Emergency room visits for deterioration of HF requiring IV or additional PO diuretics: <24-hour stay in hospital/emergency room with clinical evidence of HF.
  7. Referral to Hamilton Health Sciences HF clinic or other institution.
  8. Quality adjusted survival
  9. Overall costs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Men and women, age more or equal to 65 years AND
  2. Diagnosis of HF confirmed with the following criteria:

    1. Previous hospital admission for HF OR
    2. Definite HF confirmed with the Boston HF criteria OR
    3. Possible HF confirmed with the Boston HF criteria AND evidence of left ventricular systolic dysfunction (left ventricular ejection function <40%) on echocardiography, radionuclide angiography, or left ventricular angiogram documented in the patient’s family physicians clinic chart.

Exclusion Criteria:

  1. Patients with terminal illness (e.g. cancer) with a life expectancy of less than one year.
  2. Patients in a long-term-care facility with nursing care.
  3. Patients awaiting cardiac surgery for correctable causes of HF (e.g., severe valvular disease or extensive ischemia) during the study period.
  4. Patients expected to be away from the country during the intervention period for a duration of >3 months.
  5. Patients unable or refusing to sign consent.
  6. Patients currently followed in the Hamilton Health Sciences HF clinic. These patients are excluded as they are currently enrolled in a HF disease management strategy.
  7. Patients currently enrolled in another clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00182182

Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Canada
Principal Investigator: Catherine Demers, MD, MSc, FRCPC McMaster University Identifier: NCT00182182     History of Changes
Other Study ID Numbers: HSF2004h00511
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 2006

Keywords provided by McMaster University:
Heart Failure
Family physicians
academic detailing
process of care

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases