Evaluation of a Primary Care Based Heart Failure Management Program

NCT00182182 | Unknown Phase 2

• 1 other identifier: HSF2004h00511
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Keywords

Heart Failure; Family physicians; academic detailing; process of care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Interventions

Primary care based disease management strategy BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Catherine Demers, MD, MSc, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: ECT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: July 1, 2003
• Study Completion: October 1, 2006
• Last Updated: September 11, 2006

Record last verified: 2006-09

Locations

CA (1)