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)|
|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|
|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
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 ClinicalTrials.gov identifier (NCT number): NCT00182182
|Hamilton, Ontario, Canada, L8N3Z5|
|Principal Investigator:||Catherine Demers, MD, MSc, FRCPC||McMaster University|