Evaluation of a Primary Care Based Heart Failure Management Program
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Behavioral: Primary care based disease management strategy||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Congestive Heart Failure Assessment and Management in Primary Care: CHAMP|
|Study Start Date :||July 2003|
|Estimated Study Completion Date :||October 2006|
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182182
|Hamilton, Ontario, Canada, L8N3Z5|
|Principal Investigator:||Catherine Demers, MD, MSc, FRCPC||McMaster University|