Overview

This trial is active, not recruiting.

Condition heart failure
Treatment primary care based disease management strategy
Phase phase 2/phase 3
Sponsor Hamilton Health Sciences Corporation
Collaborator Heart and Stroke Foundation of Canada
Start date July 2003
End date October 2006
Trial size 170 participants
Trial identifier NCT00182182, HSF2004h00511

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose educational/counseling/training

Primary Outcomes

Measure
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:
time frame:
ACE-inhibitor use unless contraindicated,ACE-inhibitor dosage is at >50% of clinical trial target dose,Beta-blocker use unless contraindicated.
time frame:
Each component of the score will be given one point.
time frame:

Secondary Outcomes

Measure
Disease specific quality of life (QOL)with Minnessota Living with Heart Failure.
time frame:
NYHA functional class.
time frame:
Other outcomes
time frame:
All-cause hospitalization defined as > 24-hour hospital stay including the time spent in the emergency room.
time frame:
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
time frame:
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.
time frame:
Referral to Hamilton Health Sciences HF clinic or other institution.
time frame:
Quality adjusted survival
time frame:
Overall costs
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Congestive Heart Failure Assessment and Management in Primary Care: CHAMP
Principal investigator Catherine Demers, MD, MSc, FRCPC
Description Cluster randomized clinical trial (family physician is cluster) evaluating a primary care based heart failure management strategy
Trial information was received from ClinicalTrials.gov and was last updated in September 2006.
Information provided to ClinicalTrials.gov by McMaster University.