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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

September 12, 2005
September 8, 2006
July 2003
Not Provided
  • 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.
Same as current
Complete list of historical versions of study NCT00182182 on ClinicalTrials.gov Archive Site
  • 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
  • 1. Disease specific quality of life (QOL)with Minnessota Living with Heart Failure.
  • 2. NYHA functional class.
  • Other outcomes
  • All-cause hospitalization defined as > 24-hour hospital stay including the time spent in the emergency room.
  • 2. 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
  • 3. 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.
  • 4. Referral to Hamilton Health Sciences HF clinic or other institution.
  • 5. Quality adjusted survival
  • 6. Overall costs
Not Provided
Not Provided
 
Evaluation of a Primary Care Based Heart Failure Management Program
Congestive Heart Failure Assessment and Management in Primary Care: CHAMP

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

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Heart Failure
Behavioral: Primary care based disease management strategy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
170
October 2006
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00182182
HSF2004h00511
Not Provided
Not Provided
Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Canada
Principal Investigator: Catherine Demers, MD, MSc, FRCPC McMaster University
McMaster University
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP