Back to resultsEvaluation of a Primary Care Based Heart Failure Management Program
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Primary care based disease management strategy
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Heart Failure focused on measuring Heart Failure, Family physicians, academic detailing, process of care
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- McMaster University
Outcomes
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
Full Information
NCT ID
NCT00182182
First Posted
September 12, 2005
Last Updated
September 8, 2006
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Heart and Stroke Foundation of Canada
1. Study Identification
Unique Protocol Identification Number
NCT00182182
Brief Title
Evaluation of a Primary Care Based Heart Failure Management Program
Official Title
Congestive Heart Failure Assessment and Management in Primary Care: CHAMP
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Heart and Stroke Foundation of Canada
4. Oversight
5. Study Description
Brief Summary
Evaluation of a primary care based (family physicians) HF management strategy in patients with heart failure in the community
Detailed Description
Cluster randomized clinical trial (family physician is cluster) evaluating a primary care based heart failure management strategy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Family physicians, academic detailing, process of care
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Primary care based disease management strategy
Primary Outcome Measure Information:
Title
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:
Title
ACE-inhibitor use unless contraindicated,ACE-inhibitor dosage is at >50% of clinical trial target dose,Beta-blocker use unless contraindicated.
Title
Each component of the score will be given one point.
Secondary Outcome Measure Information:
Title
Disease specific quality of life (QOL)with Minnessota Living with Heart Failure.
Title
NYHA functional class.
Title
Other outcomes
Title
All-cause hospitalization defined as > 24-hour hospital stay including the time spent in the emergency room.
Title
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
Title
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.
Title
Referral to Hamilton Health Sciences HF clinic or other institution.
Title
Quality adjusted survival
Title
Overall costs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Demers, MD, MSc, FRCPC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Primary Care Based Heart Failure Management Program
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