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Evaluation of a Primary Care Based Heart Failure Management Program

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by McMaster University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182182
First received: September 12, 2005
Last updated: September 8, 2006
Last verified: September 2006
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Congestive Heart Failure Assessment and Management in Primary Care: CHAMP

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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:
  • ACE-inhibitor use unless contraindicated,ACE-inhibitor dosage is at >50% of clinical trial target dose,Beta-blocker use unless contraindicated.
  • Each component of the score will be given one point.

Secondary Outcome Measures:
  • Disease specific quality of life (QOL)with Minnessota Living with Heart Failure.
  • NYHA functional class.
  • Other outcomes
  • All-cause hospitalization defined as > 24-hour hospital stay including the time spent in the emergency room.
  • 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
  • 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.
  • Referral to Hamilton Health Sciences HF clinic or other institution.
  • Quality adjusted survival
  • Overall costs

Estimated Enrollment: 170
Study Start Date: July 2003
Estimated Study Completion Date: October 2006
Detailed Description:

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

  Eligibility

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

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.
  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: NCT00182182

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Canada
Investigators
Principal Investigator: Catherine Demers, MD, MSc, FRCPC McMaster University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00182182     History of Changes
Other Study ID Numbers: HSF2004h00511
Study First Received: September 12, 2005
Last Updated: September 8, 2006
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014