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
Heart and Stroke Foundation of Canada
Information provided by:
First received: September 12, 2005
Last updated: September 8, 2006
Last verified: September 2006
Evaluation of a primary care based (family physicians) HF management strategy in patients with heart failure in the community
Behavioral: Primary care based disease management strategy
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
||Congestive Heart Failure Assessment and Management in Primary Care: CHAMP
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:
| Study Start Date:
| Estimated Study Completion Date:
Cluster randomized clinical trial (family physician is cluster) evaluating a primary care based heart failure management strategy
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Men and women, age more or equal to 65 years AND
Diagnosis of HF confirmed with the following criteria:
- Previous hospital admission for HF OR
- Definite HF confirmed with the Boston HF criteria OR
- 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.
- Patients with terminal illness (e.g. cancer) with a life expectancy of less than one year.
- Patients in a long-term-care facility with nursing care.
- Patients awaiting cardiac surgery for correctable causes of HF (e.g., severe valvular disease or extensive ischemia) during the study period.
- Patients expected to be away from the country during the intervention period for a duration of >3 months.
- Patients unable or refusing to sign consent.
- 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.
- Patients currently enrolled in another clinical trial.
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
|Hamilton, Ontario, Canada, L8N3Z5 |
Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Canada
||Catherine Demers, MD, MSc, FRCPC
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2005
||September 8, 2006
||Canada: Health Canada
Keywords provided by McMaster University:
process of care
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014