NCT00211289

Brief Summary

The emphasis of this grant is to investigate ways to educate patients, not only to improve their knowledge about medications and diet that are important for better outcomes in heart failure, but also to try to understand how patients' beliefs about medication and diet affect their behaviour and to what extent the investigators can help patients change. Hypotheses: Heart failure patients who receive an enhanced educational intervention from their community pharmacist will:

  1. 1.have an absolute risk reduction in the number of events of 20%,
  2. 2.be more compliant,
  3. 3.demonstrate less health-related quality of life (HRQoL) impairment as measured by disease-specific and generic HRQoL instruments and
  4. 4.have lower costs/quality adjusted life years due to fewer total events per patient.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
383

participants targeted

Target at P50-P75 for phase_3 heart-failure

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Last Updated

March 25, 2025

Status Verified

June 1, 2005

Enrollment Period

6.2 years

First QC Date

September 13, 2005

Last Update Submit

March 20, 2025

Conditions

Keywords

Educational InterventionsHeart FailureCompliance

Outcome Measures

Primary Outcomes (1)

  • Clinical Outcomes: data collected on all cause mortality, all cause readmissions and all cause emergency room visits

    at one year

Secondary Outcomes (2)

  • Baseline outcome measurements and quality of life

    One year

  • Medication compliance

    One year

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical history of dyspnea
  • Concurrent physical exam consistent with rales, S3, elevated JVP, pedal oedema
  • Heart failure (HF) confirmed by attending physician, if patient is assessed by house staff
  • Left ventricular ejection fraction (LVEF) \< 40% on echocardiogram, nuclear scan or contrast ventriculography
  • Indications for chronic medical treatment for HF
  • Able and willing to give informed consent
  • Over 18 years of age
  • Live within London, Ontario and surrounding area, defined by the boundaries as the London and District Pharmacists' Association

You may not qualify if:

  • Planned surgical correction for HF within 12 months
  • Cor pulmonale and only right ventricular failure
  • Chronic renal failure on dialysis (these patients are followed by nephrology educators)
  • Other illnesses with survival anticipated for \< 12 months
  • Dementia documented by attending physician
  • Psychiatric illness that makes it impossible to respond to education through the community pharmacist
  • Planned discharge to long term institution
  • Barrier to teaching (English is not the first language AND caregiver cannot provide translation to the patient to elicit the patient's responses)
  • Severe alcohol or drug abuse
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Hotel Dieu Grace Hospital

Windsor, Ontario, N9A 1E1, Canada

Location

MeSH Terms

Conditions

Heart FailurePatient Compliance

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Femida H Gwadry-Sridhar, PhD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

July 1, 2002

Primary Completion

September 1, 2008

Last Updated

March 25, 2025

Record last verified: 2005-06

Locations