Primary care based disease management strategy in Heart Failure - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Heart Failure

Intervention / Treatment

Behavioral: Primary care based disease management strategy

Detailed Description

Cluster randomized clinical trial (family physician is cluster) evaluating a primary care based heart failure management strategy

Study Type

Interventional

Enrollment

170

Phase

Phase 2
Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Hamilton, Ontario, Canada, L8N3Z5
    - McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Men and women, age more or equal to 65 years AND
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:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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:
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Heart and Stroke Foundation of Canada

Investigators

Principal Investigator: Catherine Demers, MD, MSc, FRCPC, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion

October 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria