Trial of Education and Compliance in Heart Dysfunction (TEACH)
2 other identifiers
interventional
383
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 heart-failure
2 active sites
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
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedMarch 25, 2025
June 1, 2005
6.2 years
September 13, 2005
March 20, 2025
Conditions
Keywords
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
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
Hotel Dieu Grace Hospital
Windsor, Ontario, N9A 1E1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Femida H Gwadry-Sridhar, PhD
London Health Sciences Centre
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