NCT00211289

CompletedPhase 3

Trial of Education and Compliance in Heart Dysfunction (TEAC...

London Health Sciences Centre Source

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Other study identifiers

Sponsor study identifier

09091E

Secondary identifiers

HSFO NA-5047

Study Type

interventional

Estimated enrollment

383

Locations

1 country

Sites

2

Timeline

Study Start

July 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2008

Actual (reported)

Study Completion

Not reported

Date not reported

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 383 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2002
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 13, 2005
Actual (reported)
First Posted
September 21, 2005
Actual (reported)
Primary Completion
September 2008
Actual (reported)

Last Updated: March 25, 2025
Status Verified: June 2005
Last Update Submitted: March 20, 2025

Conditions

Heart Failure

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

Education by community pharmacistBehavioral

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

London Health Sciences Centre
Otherlead

Study Sites (2)

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Hotel Dieu Grace Hospital

Windsor, Ontario, N9A 1E1, Canada

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 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2008

Actual (reported)

NCT00336336

GISSI-HF- Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic CHF

Phase 3Completed

NCT02674438

Comparison of Outcomes and Access to Care for Heart Failure Trial

Phase 3Completed

NCT00206310

Crestor Versus Placebo in Subjects With Heart Failure

Phase 3Completed

NCT07270367

Finerenone and Cardiac Remodeling

Phase 3Not Yet Recruiting

NCT00407446

PDE5-Inhibition With Sildenafil in Chronic Heart Failure

Phase 3Completed

NCT00372762

Bumetanide Versus Furosemide in Heart Failure

Phase 3Withdrawn

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.

Last Updated

March 25, 2025

Record last verified: 2005-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00211289
Data provider: ClinicalTrials.gov
Source updated: 2025-03-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:13 UTC

Locations

CA(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations