CClinicalTrials.gg
Status unknownNCT00182182Updated Sep 11, 2006

Evaluation of a Primary Care Based Heart Failure Management Program

A Phase 2/3 interventional study of Primary care based disease management strategy in Heart Failure, sponsored by Hamilton Health Sciences Corporation. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-09-11.

Sponsored by Hamilton Health Sciences Corporation · Phase 2/3, Interventional, and Educational/counseling/training

The sponsor has not verified this record recently (last verified Sep 2006), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed description

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

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Conditions studied

  • Heart Failure

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Keywords

  • Heart Failure
  • Family physicians
  • academic detailing
  • process of care
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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 170 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Hamilton Health Sciences Corporation is the lead sponsor of 237 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Educational/counseling/training
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants

Interventions

  • BehavioralPrimary care based disease management strategy
06

What researchers measure

Primary outcomes

  1. 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:

  2. ACE-inhibitor use unless contraindicated,ACE-inhibitor dosage is at >50% of clinical trial target dose,Beta-blocker use unless contraindicated.

  3. Each component of the score will be given one point.

Secondary outcomes

  1. Disease specific quality of life (QOL)with Minnessota Living with Heart Failure.

  2. NYHA functional class.

  3. Other outcomes

  4. All-cause hospitalization defined as > 24-hour hospital stay including the time spent in the emergency room.

  5. 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

  6. 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.

  7. Referral to Hamilton Health Sciences HF clinic or other institution.

  8. Quality adjusted survival

  9. Overall costs

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Study locations

1 site
  • McMaster University
    Hamilton, Ontario L8N3Z5, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00182182
Lead sponsor
Hamilton Health Sciences Corporation
Collaborators
Heart and Stroke Foundation of Canada
First posted
Sep 16, 2005
Start date
Jul 2003
Completion
Oct 2006
Last update
Sep 11, 2006

Study contacts

Catherine Demers, MD, MSc, FRCPC
principal investigator · McMaster University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

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